Field

Description

Product Details

Product Description

(B.4.k.2.1/D.8.r.1/D.10.8.r.1/G.k.2.2)

The description of the product.

Use the Company Product Lookup for capturing additional information on the product.

1. Click the Lookup icon.
   The Lookup window appears.

2. Enter the search criteria and click OK.
   The search results appear in the list.

3. Choose the required information from the list and click Select.
   The selected information appears in the Full Data Entry page.

Product Evaluation

Product Available For Evaluation?

B.4.k.2.FDA.5

Indicates the availability of the medical device for evaluation.

Product Returned?

To indicate the medical device returned, select one of the following options:

• Yes

• No

• Destroyed - Select this option if the product is destroyed by the reporter without sending it for further analysis to the manufacturer or the importer.

Returned To Manufacturer On

B.4.k.2.6.FDA.1b

Date of returning the medical device to the manufacturer.

Device Evaluated By Mfg.?

To indicate that the manufacturing company estimated the device, select one of the following options:

Not returned to manufacturer

• Yes

• No

If Not Returned

If you the product is not returned, then select appropriate current status of the device.

The status may be intended plan to dispose, return or safely destroy the device.

Reason Why Device Was Not Evaluated?

The reason for not evaluating the device.

For example: The device fails the evaluation because literature with relevant usable data like User manual, device operation guide were not having enough information or intelligible information of the medical device.

Evaluation Summary Attached?

To indicate the evaluation summary attached with the device, select one of the following options:

• Yes

• No

Explanation Attached

The case has an explanation attached with it.

Reason For Not Providing Explanation

The reason for not providing an explanation about the device evaluation.

Date Product Received

Date of receiving the product.

Received By

Indicates the name of the receiver of the the product evaluation.

1. Click the Lookup icon.
   The Lookup window appears.

2. Enter the search criteria and click OK.
   The search results appear in the list.

3. Choose the required information from the list and click Select.
   The selected information appears in the Full Data Entry page.

The user name appears in the Received by field.

Condition Of Product (Visual Examination)

The details on the product condition after examining visually.

Similar Incident References

Enter details about similar incidents of Adverse event caused due to the device.

Reported Before

To specify whether similar adverse event occurred earlier is reported.

No. Of Similar Incidents

Indicates number of times the same incident is reported for a specific case.

Corrective Action Agreed To Take In Countries

Enter the details of the corrective action to be taken in various countries for preventing the occurrence of the Adverse reaction

Malfunction?

Indicate if the outcome of the reaction was a case of malfunction.

• Yes

• No

Projected Timing

Enter details about the time required to take the corrective action.

Start Date

Specify the Start date of the similar incidents and devices in the market for the time periods.

The start date of Time Period (N-1) Current Year-1, Time Period (N-2) Current Year-2 and Time Period (N-3) Current Year-3, calculates automatically.

No. of devices on market End Date

The end dates of Time Period (N-1) Current Year-1, Time Period (N-2) Current Year-2 and Time Period (N-3) Current Year-3, calculates automatically.

Country of Incident

• No of similar incidents- Specify the number of similar incidents based on the specified time period for the Country Of Incident.

• No. of devices on market- Specify the number of devices on market based on the specified time period for the Country Of Incident.

You may enter multiple records.

EEA+CH+TR

• No of similar incidents- Specify the number of similar incidents based on the specified time period for the EEA+CH+TR.

• No. of devices on market- Specify the number of devices on market based on the specified time period for the EEA+CH+TR.

You may enter multiple records.

World

• No of similar incidents- Specify the number of similar incidents based on the specified time period for the world.

• No. of devices on market- Specify the number of devices on market based on the specified time

Usage Of Device

Usage Of Device

B.4.k.20.FDA.15

To indicate the usage of the device, select one of the following options:

• Initial use of device

• Re-serviced / refurbished

• Unknown

• Re-use

• Reuse of a single use medical device

• Other (please specify)

• Reuse of a reusable medical device

• Problem noted prior use

Device Usage Other Text

Indicates if there is any other way the device was used specifically to be mentioned or any other extra details of the usage of the device to be considered in the case. It is a free text field.

Labeled Single Use?

B.4.k.20.FDA.12

Indicates if the device has any label suggesting only one time usage.

Priority

The order of precedence or the condition of being considered more important than the usage of some other device.

For example: High Priority - The respective device has higher importance than the other devices mentioned in the case.

First Awareness Date

The initial date of making the device known.

The first awareness date is auto populated with the value from General>Initial received date>First awareness date.

If the product type is device, Then only for the Device and Combination the first awareness date gets auto populated with the value in Initial received date.

Correction/Removal #

The correction or removal number for the Incident.

If Remedial Action Initiated, Check Type

B.4.k.20.FDA.14.1a

B.4.k.20.FDA.14.1e

B.4.k.20.FDA.14.1b

B.4.k.20.FDA.14.1f

B.4.k.20.FDA.14.1c

B.4.k.20.FDA.14.1g

B.4.k.20.FDA.14.1d

B.4.k.20.FDA.14.1h

B.4.k.20.FDA.14.1i

These are the types of the remedial actions that are initiated by the data entry person.

Recall - Indicates that the manufacturer has recalled the faulty medical device that has caused the Adverse Event.

Notification - Indicates that the manufacturer has notified the faulty medical device to the authority.

Repair - Indicates that the manufacturer has repaired the faulty medical device that has caused the AE.

Inspection - Indicates that the manufacturer has inspected the faulty medical device that has caused the AE.

Replace - Indicates that the manufacturer has replaced the faulty medical device that has caused the AE.

Patient Monitoring - Indicates that the patient who has experienced the AE is being monitored.

Relabelling - Denotes that the manufacturer has relabeled the faulty medical device that has caused the AE.

Modification/Adjustment - Signifies that the faulty medical device that has caused the AE has been modified/adjusted by the manufacturer.

Other - Indicates if there are Other remedial actions initiated.

Describe Other

If the remedial measures initiated, they can be mentioned and described here.

Device Used for

A device is generally classified for diagnosing or investigating reported event, treating or testing a disease. For utilizing the device, the pharmaceutical companies must obtain the license from the respective authority of the country. However, in certain emergency therapies, a program may be approved by the authority to allow the manufacturer to utilize the device for which the license is not yet obtained under Special Access Program.

This field provided you three classification of using the device as follows:

• Investigational Testing – Select this option when the device utilized for discovering or testing the reported events or testing the specimens, blood sample and so on.

• Special Access Program – Select the option if the device that is utilized under approved program of utilizing the device for which the license are not yet obtained or approved.

• Radiation Emitting Device – Select this option if the device is utilized in radiation therapies like MRI scanning, X-Ray etc.

Performed By

To indicate who performed the analysis for preventive action:

1. Click the Lookup icon.
   The Lookup window appears.

2. Enter the search criteria and click OK.
   The search results appear in the list.

3. Choose the required information from the list and click Select.
   The selected information appears in the Full Data Entry page.

The user name appears in the Performed by field.

Device Serviced by Third Party

Indicates if the device is serviced by the third party.

The available options are:

• No

• Unknown

• Yes

Medical Codes Information

FDA Type of Investigation  

FDA Investigation Findings

FDA Investigation Conclusions

FDA Health Effect Clinical Code Device

FDA Medical Device Problem Code

FDA Health Effect Impact Code

FDA Component Code

B.4.k.20.FDA.19.

B.4.k.20.FDA.19.1b

Method - Type of medical device code. These can be retrieved by invoking the device coding manual lookup.

The search results appear based on the codelist language selected in the User Preference screen.

you may select the code classification with the help of the drop-down list. These values are printed in the Manufacturer’s device  analysis results section of the Mfr. Incident Report.

The available code classifications options are:

• FDA Type of Investigation

• FDA Investigation Findings

• FDA Evaluation

• FDA Investigation Conclusions

• FDA Health Effect Clinical Code

• FDA Medical Device Problem Code

• FDA Health Effect Impact Code

• FDA Component Code

• IMDRF Problem Code Term (Annex A)

• IMDRF Investigation Term (Annex B)

• IMDRF Investigation Finding Term (Annex C)

• IMDRF Investigation Conclusion Term (Annex D)

• IMDRF Health Effect Term (Annex E)

• IMDRF Heath Impact Term (Annex F)

• IMDRF Component Code Term (Annex G)

IMDRF Terms

Problem Code Term

Select the problem code terms used for FDA reporting and the IMDRF codes for EU reporting with the help of the Device Coding Manual look up option.

The search results appear based on the codelist language selected in the User Preference screen.

The selected code term and decode value appears.

You may enter multiple records using the navigation option.

Other Than Problem Code,Explain

Explain the other problem code, if the incident is unique and the suitable IMDRF term is unavailable.

Investigation Term

Select the investigation term used for FDA reporting and the IMDRF codes for EU reporting with the help of the Device Coding Manual look up option.

The search results appear based on the codelist language selected in the User Preference screen.

The selected code term and decode value appears.

You may enter multiple records using the navigation option.

Investigation Finding Term

Select the investigation finding term used for FDA reporting and the IMDRF codes for EU reporting with the help of the Device Coding Manual look up option.

The search results appear based on the codelist language selected in the User Preference screen.

The selected code term and decode value appears.

You may enter multiple records using the navigation option.

Investigation Conclusion Term

Select the investigation conclusion term used for FDA reporting and the IMDRF codes for EU reporting with the help of the Device Coding Manual look up option.

The search results appear based on the codelist language selected in the User Preference screen.

The selected code term and decode value appears.

You may enter multiple records using the navigation option.

Other Than Investigation,Explain

Explain the other investigation, if the incident is unique and the suitable IMDRF term is unavailable.

Health Effect Term

Select the health effect term used for FDA reporting and the IMDRF codes for EU reporting with the help of the Device Coding Manual look up option.

The search results appear based on the codelist language selected in the User Preference screen.

The selected code term and decode value appears.

You may enter multiple records using the navigation option.

Heath Impact Term

Select the health impact term used for FDA reporting and the IMDRF codes for EU reporting with the help of the Device Coding Manual look up option.

The search results appear based on the codelist language selected in the User Preference screen.

The selected code term and decode value appears.

You may enter multiple records using the navigation option.

Other Than Health Effect,Explain

Explain the other health effects, if the incident is unique and the suitable IMDRF term is unavailable.

Component Code Term

Select the component code term used for FDA reporting and the IMDRF codes for EU reporting with the help of the Device Coding Manual look up option.

The search results appear based on the codelist language selected in the User Preference screen.

The selected code term and decode value appears.

You may enter multiple records using the navigation option.

Other Than Component Code,Explain:

Explain the other component code, if the incident is unique and the suitable IMDRF code is unavailable.