Entering and Reviewing Data for MDV Reports

When you populate the regulatory report, many fields are copied from the product issue record. When you edit these fields in the regulatory report record, the edits are not copied back to the product issue record.

Note: The process described here is to enter data in the MDV view in the Regulatory Reports screen. However, an alternate way is to enter the data in the MDV view in the Product Issues screen before the regulatory report is populated. If you use this alternative, you have copies of the data in both the product issue record and in the regulatory report record.

This task is a step in Process of Regulatory Reporting.

To review and enter data for an MDV Initial report

1. Navigate to Regulatory Reports screen, then the Regulatory Report List view.

2. In the Regulatory Report List, drill down on an MDV regulatory report record.

3. Review and if necessary modify the information in the More Info and Patient views.

4. Click the MDV tab.

5. On the MDV form, complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   MDV Report #	MDV Report number. This number is auto-populated when the report is generated.
   Authorities	The name of the regulatory agencies to send the report to.
   Affiliate Acct	The affiliate account representing the company.
   PI Received	The date when the company became aware of the event.
   Determination	The type of the reportable event for MDV reporting.
   Patient Codes	Patient codes describe what happened to the patient as a result of the event.
   Device Codes	Device codes describe device failures or problems encountered during the event.
   Usage of Device	Indicates whether the use of the suspect medical device was the initial use, reuse, or unknown.
   Follow-up Date	Date field to indicate the approximate follow-up or final report date.
   Approval Org	The approval body for the device.
   Approval #	The approval number for the device.
   Evaluation	If the evaluation was conducted, note summary here and choose Evaluation Summary Attached in Evaluated by Mfg field.
   Mfg Narrative	Any additional information, evaluation, or clarification of data presented in previous sections.