Enter product information

Enter the following information in the Device tab:

M/W Info dialog box

The MW Info dialog box allows you to enter the following device information:

Is this a single-use device that was reprocessed and reused on a patient?—Indicate whether the device was labeled for single use. If the question is not relevant to the device being reported (for example, an X-ray machine), leave the select box cleared.
Reprocessor Name—Enter information for Address 1, Address 2, City, State, Country, Postal Code, Fax, and Email Address.
Select if the device was an Adverse Event or a Product Problem.
Type of Follow-up Report—Select a checkbox that describes the nature of the follow-up (supplemental) report:
Correction—Changes to previously submitted information.

Additional information—Information concerning the event that was not provided in the initial report because it was not known/available when the report was originally submitted.

Response to FDA request—Additional information requested by FDA concerning the device/event.

Device Evaluation—Evaluation/analysis of the device.
Device Evaluated by Mfr—Select the Not returned to mfr. checkbox if an evaluation could not be made because the device was not returned to or made available to the manufacturer.
Select Yes if an evaluation was made for the suspect medical device. You can attach a summary of the evaluation and select Yes, Summary Attached.

If an evaluation of a returned suspect or related medical device was not conducted, check the No checkbox and attach an explanation or provide an appropriate code from the coding manual (Part II, Subpart A).
Reason for Non-Evaluation—Enter the reason for the device not being evaluated by the manufacturer.
Other Reason for Non-Evaluation
If remedial action initiated, check type—Select the applicable actions. If other, specify the type of action in the space provided (for further reference, see 21 U.S.C. 360h and 21 CFR part 803).
Usage of Device—Make a selection to indicate whether the use of the suspect medical device was the initial use, reuse, or unknown.
USC 360i(f) correction/removal reporting number—Enter the number that the FDA assigned to the corrective action. If the FDA has not yet assigned a number, the internal number assigned to the action by the company is used.
Additional manufacturer narrative—Check the checkbox (if applicable) and enter any additional information, evaluation, or clarification of data presented in previous sections.
Corrected Data—Check if the data is corrected.

EU/CA Device dialog box

The EU/CA Device dialog box allows you to enter the device information. Fields are marked by either an EU flag or a Canadian flag to indicate which entity is mapped to the field.

Associated Devices—Enter the associated devices with the device.
Associated Accessories—Enter the associated accessories with the device.
Firmware version—Enter the firmware version.
Periodic Summary Report (PSR) ID—Enter the PSR ID, if any.
Identification of Notified Body involved in Conformity Assessment—Enter identification number of the Notified Body involved in the conformity assessment procedure (if any) and the date(s) of the attestation(s).
Remedial Action by HC Facility—Enter the remedial action taken by the Healthcare facility.
Update to Initial Report (Follow-up Report)—Check if the Follow-up report must be updated to an Initial report.
Availability of Device—Select whether the device was Destroyed, Returned to Manufacturer/Importer, or Neither.
Current location of device—Enter the present location of the device that was involved in the incident.
Other—This field is enabled when you select Other in the Current location of the device drop-down.
Final Report—Check if this is the final report.
MIR Report Type—Select the MIR report type as Follow-up Report, Final (Reportable), or Final (Not Reportable).
Rationale for Not Reportable—Enter the reason why the considered report is not reportable. This field is enabled when the MIR Report Type is selected as Final (Not Reportable).
Where was the device purchased—Enter the establishment where the device was purchased.
Root cause confirmed—Select an option.
Risk assessment—Specify if the risk assessment has been reviewed and is adequate. Select an option as Reviewed and Adequate, Reviewed and Not Adequate, or Not Reviewed.
Rationale—Enter the reason for why a review is not required. This field is enabled when the Risk assessment is selected as Not Reviewed.
Results of Assessment—Enter the results of assessment.
Marketed Device Variant/Subset—Enter the value for device variant or subset.
The valid values are:

0 – Model

1 – Software

2 – Other Variant

3 – Lot/Batch

Similar Incidents dialog box

Similar incidents occurring with the same device type or variant of a given manufacturer with the same investigation finding (IMDRF investigation finding; Annex C) and the same medical device problem (IMDRF medical device problem; Annex A) have to be reported to National Competent Authorities (NCA) and European Commission (EC).

Identification and computation of the count of similar incidents is done outside the application. The application captures the fields for the provided results.

Similar Incident Device Category—Select the device or device variant used for identification of the similar incidents.
Details of the Device Category—Enter the details of the selected device or device variant.
Criteria for Number of Devices on the Market—Select the criteria used for the number of devices in the market.
Other—This field is enabled only when you select Other in the Criteria for Number of Devices on the Market field. Describe the criteria.
Similar Incident Analysis Based on—Select the details based on the similar incident analysis.
Rationale—This field is enabled only when you select Other IMDRF Annex or Other Inhouse Codes in the Similar Incident Analysis Based on drop-down.
Inhouse Medical Device Problem Code and Term—Enter the most relevant in-house medical device problem code and term used for identification of similar incidents. This field is enabled only when you select Inhouse Codes in the Similar Incident Analysis Based on drop-down.
Inhouse Evaluation Result/Findings Code and Term—Enter the most relevant in-house root cause evaluation code and term used for identification of similar incidents. This field is enabled only when you select Inhouse Codes in the Similar Incident Analysis Based on drop-down.
Start Date—Enter the start date for the period for which the analysis of similar incidents is performed.
End Date—Enter the end date for the period for which the analysis of similar incidents is performed.
No of Similar Incidents in Incident Country—Enter the number of similar incidents occurred in the incident country.
No of devices in Incident Country—Enter the number of devices in the incident country.
No of Similar Incidents in EEA+CH+TR—Enter the number of similar incidents that occurred in European Economic Area, (EEA), Switzerland (CH), or Turkey (TR).
No of devices in EEA+CH+TR—Enter the number of devices in European Economic Area, (EEA), Switzerland (CH), or Turkey (TR).
No of Similar Incidents in World—Enter the number of similar incidents that occurred in world.
No of devices in World—Enter the number of devices in the world.
Comments—Enter the comments for identification of similar incidents.