Device information—field descriptions

Enter the following Product Information in the Device tab:

Field or Control Name	Description
Catalog #	Under Catalog#, enter the exact catalog number as it appears in the manufacturer's catalog, device labeling, or accompanying packaging.
Implant facility	Enter the healthcare facility where the device was implanted.
Explant facility	Enter the healthcare facility where the device was explanted.
UDI System	The UDI System captures the unique identification type of the given device. The values displayed in this field are derived from the DEVICE_UDI_SYSTEM flexible code list.
Unique Identifier (UDI) #	Under Unique Identifier (UDI) #, enter any other applicable identification number (for example: component number, product number, part number, bar-coded product ID). Data is entered in such a way to handle the UDI Device identifier and UDI Production Identifier fields.
UDI -DI	Enter the UDI device identifier.
Issuing Entity UDI-DI	Select from the drop-down the issuing entity for the UDI device identifier.
UDI-PI	Enter the UDI-Product identifier.
Unit of Use UDI-DI	The values displayed in this drop-down are based on the UDI-DI attribute form the DEVICE_UDI_SYSTEM flexible code list.
Issuing Entity Unit of use UDI-DI	The values displayed in this drop-down are based on the Unit of UDI-DI attribute form the DEVICE_UDI_SYSTEM flexible code list.
Serviced by Third Party	Enables you to capture whether the device was serviced by a third party. The possible values are: Yes No Unknown
FDA Exemption Number	This field is available for the eMDR report and provides a number provided by the FDA. This field enables you to track the approved exemptions or variances of the adverse event reporting.
Preliminary Comments	This free text field allows you to enter preliminary comments, up to a maximum of 4000 characters.
Operator of Device	Select the type of person operating or using the suspect medical device on the patient at the time of the event such as Health Care Professional, Patient, Paramedic and so on.
If Other	If the operator of the device is other, enter the operator of the device.
Malfunction Type	Make a selection to indicate the type of reportable event. For an event associated with a malfunction, the FDA refers to applicable sections in 21 CFR Part 803 reporting guidelines.
Device Outcome	The values in this drop-down are derived from the standard Device outcome code list.
Device Outcome Detail	This field is enabled when the Device Outcome field is set to Other.
Device Comments	Allows you to enter details about the device.
Concomitant Device Comments	This free text field allows you to enter details about the concomitant device. It is always enabled for all products, suspect and concomitant.
Device Available for Evaluation	Indicate whether the device is available for evaluation. Also, indicate whether the device was returned to the manufacturer and if so, the date of the return.
CE Marked	Select whether the device is CE Marked or not. This information is preloaded from License information for a case booked manually, through E2B or LAM, and can be modified as needed.
Similar Device	Check this check box when you report similar devices to FDA. You must report similar devices when a device causes reportable malfunction and it is likely that malfunction can occur in similar devices. Similar devices are identified in a case when this check box is checked along with the Drug not administered check box being checked and Product Type set to Treatment/Other.

Enter the following Malfunction Information in the Device tab:

Field or Control Name	Description
Reported Malfunction	Enter the malfunction as entered by the reporter.
Determined Malfunction	Enter the malfunction as determined by the company.
Listedness	Enter the listedness of malfunction in respect of the device.
Reportable	Select the reportability of the malfunction.

Enter the remaining fields:

Field or Control Name	Description
Patient Problem and Device Problem Information	This section captures the problem details for a device. It contains the following fields: FDA Code (for patient problem) (read-only) Patient Problem (read-only) FDA Code (for device problem) IMDRF Code Device Problem Term Patient Problem and related FDA code are read-only fields and code select option was removed. Any legacy data available can be viewed here. Use the Device Problem lookup to select the device problem information, like device problem, FDA code, and IMDRF code. A single red cross icon is displayed at the beginning of the record if the record contains one or more invalid IMDRF codes.
Evaluation/Investigation Code Information	To enter the applicable codes from the categories listed, click Select. It contains the following fields: FDA Code IMDRF Code Method/Type Term Result/Findings Term Conclusion Term Follow the instructions in the dialog box to enter the evaluation codes. Conclusion codes must be entered even if the device was not evaluated. A single red cross icon is displayed at the beginning of the record if the record contains one or more invalid IMDRF codes.
Health Impact Information	This section captures the health related information. It contains the following fields: Health Impact IMDRF Code Health Impact Term A single red cross icon is displayed at the beginning of the record if the record contains one or more invalid IMDRF codes.

Note:

If a case contains an obsolete IMDRF code, it is indicated by a red cross against that record to signal that the case is not encoded.

The IMDRF encoding is independent of FDA code update. You can load and view IMDRF data without requiring FDA code, providing greater flexibility and ease of use.