Device information—field descriptions

• You can enter up to 10,000 characters in the Additional Manufacturer Narrative field.
• The device evaluation codes have been updated to reflect FDA standards. Go to the following link for more information: http://www.fda.gov
• The evaluation method is available is the following site: http://www.fda.gov
• The evaluation results are available at the following site: http://www.fda.gov

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 valid values are: GS1 – Global Standards 1 HIBCC - Health Industry Business Communications Council ICCBBA - The International Council for Commonality in Blood Banking Automation
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.
UDI-PI	Enter the UDI-Product identifier.
Unit of Use UDI-DI	Enter the Unit of Use UDI-DI.
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 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 patient or device. It contains the following fields: FDA Code (for patient problem) Patient Problem FDA Code (for device problem) IMDRF Code Device Problem Term Use the Patient Problem and Medical Device Problem lookups to search the problem information.
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.
Health Impact Information	This section captures the health related information. It contains the following fields: IMDRF Code Health Impact Term
Incident Information	This section captures the incident details. It contains the following fields and supports multi-record entry. The Event Type Level codes are cascading, that is, Event Level 2 depends on 1. Event Type Level 1 Event Type Level 2 Manufacturer Event Type Level 3 Event Type Level 3 Description
Manufacturers Final Investigation Results	This section captures the investigation details. It contains the following fields and supports multi-record entry. The Evaluation Type Level codes are cascading, that is, Evaluation Level 2 depends on 1. Evaluation Type Level 1 Evaluation Type Level 2 Manufacturer Evaluation Type Level 3 Evaluation Type Level 3 Description

EU/CA device dialog box—field descriptions

Field or Control Name	Field Length	Field Type
NCA Reference Number	100 characters	Alphanumeric
Identify to what other NCA's this report was also sent	2000 characters	Alphanumeric
Number of Patients Involved	3 characters	Numeric
Number of Devices	3 characters	Numeric
User facility reference number	20 characters	Alphanumeric
Remedial Action by HC Facility	1000 characters	Alphanumeric
Usage of Medical Device	N/A	Checkbox
Other	15 characters	Alphanumeric
Update to Initial Report (Follow-up Report)	N/A	Checkbox
Final Report	N/A	Checkbox

When you select the EU/CA Device option, the fields on the Case form are printed. A track of the fields and any updates are maintained in the audit log.