Field

Description

Product/Manufacturer

General

Product Type

A.1.FDA.15

• Device: Type of the device that caused the adverse event.

• Combination: A combination product is a product composed of any combination of a drug and a device. For example: Drug-eluting stent (DES), which is coated with a drug to prevent scar tissue from growing in an artery.

     Displaying Combination product details :

1. 1. Select the Combination product from the CPD lookup,  ct The A.1.FDA.15 Drug level details are captured in the Product Information screen.

   2.  The Device level details are captured in the device screen.

   3.  The product type is set to "Combination".

Product Flag

The identification of the product as suspect, concomitant, past etc, depending on the occurrence of the adverse event.

For example, if the patient consumed the product before the event occurred, then you specify the product flag as "Past”.

Click the List button.
The Product List screen appears.

Select a record from the list and click Select.

Product Name

Name of the Product depending on the product flag selected.

The name of the product appears in the Product name field.

Associated To

Indicates, if the product is a constituent product of any combination product.

Reporting Party

The party that reported about the adverse event due to the medical device.

Select the appropriate option from the drop-down list.

Manufacturing Unit

The company that manufactured the medical device.

Or

The unit code and the unit name appears in the Manufacturing unit field.

Mfg. Site

Location of manufacturing the medical device.

Site Registration No.

Registration number of the manufacturing site.

Catalog no

B.4.k.20.FDA.6

Catalog number of the medical device that caused the adverse event.

User Facility

Select the user facility of the device from the Company Unit lookup window.

User Facility Reference No.

User facility reference number of the device that caused the adverse event.

Model No.

B.4.k.20.FDA.5

Model number of the medical device that caused the adverse event.

Serial no

B.4.k.20.FDA.7

Serial number of the  medical device that caused the adverse event.

CE No.

Certificate of excellence number for the device that caused the AE.

Expiration date (B.4.k.2.4.FDA.1b/B.4.k.2.4.FDA.1a/ G.k.4.r.CN.1)

Date on which the medical device expires. This field allows you to enter the imprecise date format.

You can enter the following imprecise date format for this field:

/ /<Year>

/<Month>/<Year>

The specified date format is printed in the FDA Device report, Austrian Device report, MFR Incident report, FSCA report, Overview report, and AER Data report.

Operator Of Device

B.4.k.20.FDA.20

The type of person operating or using the device on a patient when the event occurred is significant.

In a health center or a hospital, there may be several person ranging from their designation and qualification who may have used the device for operating on a patient.

Select the appropriate device operator from the drop-down list.

Describe

Indicates the more information about the device.

Pharmaceutical Product ID (B.1.10.8.r.a3)

An identifier assigned at the level of the pharmaceutical product based on the active ingredient(s), the strength(s) of the ingredient(s), and the pharmaceutical dose form.

Medicinal Product ID (D.8.r.2b /D.10.8.r.2b/ /G.k.2.1.1b/ G.k.2.1.KR.1b)

An identifier assigned to a medicinal product by the authorized regulatory authority of the country.

PhPID operation date (B.1.10.8.r.a4)

The operation date of the pharmaceutical product identifier to support E2B R3.

ARTG Number

ARTG (Australian Register of Therapeutic Goods) number is the number allocated to the medical or therapeutic devices that is registered or listed in the Australian Register of Therapeutic Goods to sell the medical or therapeutic devices legally within the Australia.

The application allows you to enter maximum of 70 alphanumeric characters in this field.

The application allows you to manually enter this field or the ARTG number is displayed when device is selected from the CPD lookup.

The displayed ARTG number is considered for printing in the Australian Device Report (ADR).

ARTG Mfr. number

The number assigned to the device manufacturer in the ARTG (Australian Register of Therapeutic Goods). This number is considered to print in the ADR report.

FDA 3500A(device) related fields

Type Of Device

The type of device that caused the adverse event.

Common Device Name (B.4.k.20.FDA.2)

The general or the common device name given to the device.

The device code and name appears in the Common device name field.

Procode (B.4.k.20.FDA.3)

The Product Code assigned to a device. The name and product code identify the generic category of a device.

1.Select the Common device name from the Lookup icon.

2. Click OK in the Common Device Name Lookup

3. Enter the Search critirea and click ok.

The Procode field is auto populated along with the Device name.

The user will be able to change the data auto populated in the Procode field

Japanese Device Name

The marketing name of the device recognized in Japan. The health authority, MHLW, of Japan recognizes few devices in native Japanese language that are distinct to their generic name marketed in other countries.

UDI device identifier/Eudamed ID B.4.k.20.FDA.8

Number of any other medical device that caused the adverse event.

Select Product type /Device  from the CPD lookup, the application auto populates  the UDI no for the associated product type.

The data in the UDI no field is overwritten when the product is selected from the lookup.

Basic UDI-DI/Eudamed-DI

The Basic UDI-DI of the device.

Device Manufacture date B.4.k.20.FDA.13b

Date of manufacturing the device.
Enter the date in DD/MON/YYYY format.

Date Implanted

B.4.k.20.FDA.9b

Date on which the  medical device was  implanted in the patient.

Date explanted

B.4.k.20.FDA.10b

The date on which the  implanted device was removed from the patient.

Duration Of Implantation

The overall duration for which the internal fixation device (Plate and Screws  or  Intramedullary Rods) was retained in the body. The duration of device implantation is specified in hours, days, months, and years.

Is This A Single Use Device That Was Reprocessed And Reused On A Patient?

To indicate the usage of the device. Example: If the original equipment manufacturer,  is unable to determine if their single use device was reprocessed and reused on a patient, then the manufacturer can select  Unknown.

 Select one of the following options:

• Yes

• No

• Unknown

Procode

(B.4.k.20.FDA.3)

The product code of the medical device that caused the adverse event.

The application prints the value you enter here in the Box D2 of the FDA 3500 (Device) Report.

Reprocessor

Indicates the unit that  has reprocessed the device. Example: Multiuse device

1. Enter the reprocessor unit

or

The code and name of the unit appears in the Reprocessor field.

Device Age Type

Indicates whether or not the device’s age is manually or automatically calculated.

Age

B.4.k.20.FDA.11a

The age of the device at the time of adverse event.

The device’s age is the duration between the date on which the adverse event occurred and its date of manufacture.

Device age = Onset date (B.2.i.4b/E.i.4) (earliest AE onset date) - Device mfr. Date.

Unit

B.4.k.20.FDA.11b

The unit of measuring the Device’s age. For example: Years.

Type of Submitter

Type of Submitter is the authorized person who submits the device report for the Adverse Event. The Submitter of the Report can be either manufacturer of the device or the representative who is authorized to represent the manufacturer of the device.

Select the submitter type

• Manufacturer

• Authorized Representative

• Other

Please Specify

Enter the submitter type in this field, when you select “Other” in Type of Submitter drop-down.

Related device (Chinese) (G.k.CN.2)

Enter the device information that is associated with the adverse reaction.

Mfr Incident Report related fields

Competent Authority

Select the authority to be reported about the adverse event due to the device using the lookup.

NCA Reference No.

NCA reference number of the device that caused the adverse event.

Authorized Rep. In EEA

Select the authority representative in the EEA (European Economic Area) from the lookup.

Software Ver.

Enter details from the software version for the device that indicates the cause of adverse event occurrence(s).

Exp. Follow-Up Date

The expected follow up date for the Adverse event caused by the device.

Nomenclature System

Nomenclature signifies the generic terms used for identifying the medical devices.

Select the Nomenclature System category from the drop-down list to which the Device that caused adverse event belongs.

• European Medical Device Nomenclature (EMDN)

• Global Medical Device Nomenclature

• Universal Medical Device Nomenclature

• Global InVitro Diagnostic (GIVD/EDMS)

• Others

Nomenclature Code

Enter the nomenclature code of the device that caused the adverse event.

Use the GMDN Lookup to capture the term code. The decode value displays on selection of term code from lookup or auto code.

Nomenclature system Text

Enter the nomenclature text of the device that caused the adverse event.

Nomenclature Text and Its Intended Use

Enter the nomenclature text of the device that caused the AE and its intended use.

No. Of Devices Involved

Enter the number of device involved in causing the adverse event.

No. Of Patients Involved

Enter the number of patient affected with adverse event by the usage of device.

Current Device Location

Specify where the device is located after the adverse event occurrence from the drop-down list.

Current Device Location Text

Enter the location of the current device, if the option is unavailable in the “current device location” drop-down list.

NCA's Local FSCA Reference Number

Enter the NCA reference number assigned to the FSCA that the incident covers.

EUDAMED's FSCA Reference Number

Enter the FSCA reference number assigned by EUDAMED.

Manufacturer's FSCA Reference Number

Enter the manufacturer’s FSCA reference number.

Periodic Summary Report (PSR) ID

Enter the unique PSR-ID for the incident if it is reportable under PSR.

PMCF/PMPF Eudamed ID

Enter the Eudamed ID of the incident that occurred within the PMCF/ PMPF investigation.

Firmware Ver.

The value given by the applicant to identify a specific revision of the firmware (including SaMD) (IMDRF).

Implant Facility

The healthcare facility where the device was implanted.

Explant Facility

The healthcare facility where the device was explanted.

Device Commercial Date

The date of the device that was first made available for use or put into service.

Year, Month

Enter the device commercial date (year and month).

Basis of Similar Incidents

Specify on which basis similar incidents were identified regarding the device or device variant from the drop-down list.

Details of the Selection

Specify the details of the selection made on the number of similar incidents and devices in the market.

Criteria for Devices in Market

Specify the criteria on which the number of devices in the market is based on.

Describe other Similar Incident

Describe the other criteria on which the number of devices in the market is based on.

Relevant Accessories Used with The Device

Indicate the relevant accessories used with the device being reported on.

Relevant Associated Devices Used

Indicate the relevant associated devices with the device being reported on.

EUDAMED Reference Number

The reference number assigned by Eudamed for this incident (after upload/entering incident into Eudamed).

Manufacturer Reference Number

Enter the reference numbers of the NCA, EUDAMED and manufacturer here. if there are other devices involved in the incident, enter them using semicolon.

EUDAMED Reference Number (Other Related Devices)

Enter the reference number of the incident involving other devices from the same manufacturer.

App.No./Lot.No tab

Approval Information

Trade Name

Brand name of the medical device that caused the adverse event.

Using the Company Product Lookup, select the product from the Local Tradenames tab. The product information appears in the Approval Information section.

Approval No. (B.4.k.4.1/G.k.3.1/ G.k.CN.4)

Approval number in the text box.

To generate approval number automatically, set the parameter Auto approval number generation to Yes in the Admin > Parameters > > Installation Parameters > Automatic Coding/Labeling (Mapping).

Country (B.4.k.4.2/G.k.3.2)

The country that approved the medical device.

Approval Type (J.8)

The type of approval on the medical device.

Product Type In The Country

To indicate the type of product, select one of the following options:

• Drug

• Vaccine

• Device

• Combination

Approval Submission Type

The approval submission for the product in country.

Marketing Authorization Holder (B.4.k.4.3/G.k.3.3)

The company that has the authorization to use the approval number.

Class Of Device/ /MDD/AIMDD/IVDD/MDR/IVDR

The class to which the device belongs.

There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient.

Identification No. Of Notified Body

The identification number of the body that notified the approval information.

Medicinal Product ID

The medicinal product identifier of the product to support E2B R3.

An identifier (ID) assigned to a medicinal product by the regulator of the country or territory of authorization.

While entering the product approval details in CPD (Company Product dictionary), the Medicinal Product ID and Medicinal operation date are specified. When the Product is selected from the application using Company Product look up, the medicinal product identifier is auto populated.

Canadian Device ID

The Device product identifier of the product to Health Canada authority.

An identifier (ID) assigned to a device by the regulator of the Canada.

While entering the product approval details in CPD (Company Product dictionary), the Canadian Device ID is specified. When the Product is selected from the application using Company Product look up, the Canadian Device identifier is auto populated.

PMDA Device Classification

The PMDA of Japan classifies the devise under different categories based on the certification and approval regulations framed by collaboration with the MHLW. For example, a device may be categorized in range of Low to High risk based on the risk level a patient may be exposed to while using those devices for treatment or disease detection. An X-ray apparatus is considered as Low risk as it is used to diagnose musculoskeletal problems, similarly a Stent implanted in blood vessels are high risk category.

Such devices are categorized as Class A, Class B and so on.

PMDA Biological Device

The biological device category used in treatment.

A Biological Device is manufactured using synthesized or derived from biological substances or material. For example: artificial-tissues for skin grafting or repair, Dental implants or Caps.

MedID Operation Date

The operation date of the medicinal product identifier.

Device Marketed Before MDD/AIMDD/IVDD

Select this checkbox if the device has been placed in the market before the implementation of the MDD/AIMDD/IVDD.

MDR

Select the MDR class for the device from the drop- down list.

MDR Type

Select the appropriate MDR type for the device from the mentioned options.

You may choose one or more MDR type if required.

IVDR

Select IVDR class for the device.

IVDR Type

Select the appropriate IVDR type for the device from the mentioned options.

You may choose one or more IVDR type if required.

Lot Number Information

Lot Record Reviews

To indicate the availability of Lot record reviews select one of the following options:

• Yes

• No

Lot No.

Enter the lot number found on the protective tab and carton label.

Performed By

To indicate who entered the lot number information:

The user name appears in the Performed by field.

Search Results

The result of the search performed on the lot number.

Describe

Description on the lot number. It is a free text field provided to give more details of the lot number.

Device Dealers Info. tab

Device Dealers Information

Country

The country of the device dealer.

Distributor

Company that distributed the device.

The code and name of the unit appears in the Distributor field.

Importer

Company that imported the device.

The code and name of the unit appears in the Distributor field.

Mfr. Code

Code of the company that manufactured the device.

The code and name of the unit appears in the Distributor field.

Concomitant Medical Products(Exclude Treatment of Event)

Product description

Active Ingredients

WHO DD

Reported for

To update the details on the secondary or parallel medical products, click the following links in this section:

• Add

• Delete

• Duplicate

Code for Identifying Similar Incidents

Identification of similar incidents using IMDRF Adverse Event Reporting terms and codes.

The available options are:

• Medical device problem

• Investigation finding

• Other

Other Description

Explain the identification of similar incidents using IMDRF Adverse Event Reporting terms and codes.

In-House Codes

Medical Device Problem Code

Specify the in-house medical device problem code, if similar incident were not identified by IMDRF codes.

Medical Device Problem Term

Specify the in-house medical device problem term, if similar incident were not identified by IMDRF codes.

Root Cause Evaluation Code

Specify the in-house Root cause evaluation code, if similar incident were not identified by IMDRF codes.

Root Cause Evaluation Term

Specify the in-house Root cause evaluation term, if similar incident were not identified by IMDRF codes.

Other Inhouse Codes

Select this check box if there is any other inhouse codes.

Other Inhouse Codes Description

Specify the description of the other inhouse codes.