Manufacturer analysis
Click on the Manufacturer Analysis section from the menu on the left:
Click on the plus sign next to Manufacturer’s preliminary comments:
Fill in all useful information in the three corresponding text fields:
Click on the plus sign next to Cause investigation and conclusion:
Select the appropriate option from the drop-down list:
Fill in the last three text fields of the IMDRF Component Codes section:
Click on the plus sign next to the following segment, i.e. Similar incidents:
Answer the first question on IMDRF code identification with Yes or No:
If you answered Yes, specify the Identification of similar incidents using IMDRF Adverse Event Reporting terms and codes:
If you answered No, type a description in the text box and provide in-house codes and terms to identify similar incidents in the corresponding fields shown below:
Provide information about the number of similar incidents and devices on the market:
Click on the plus sign next to Number of incidents:
Select the appropriate dates from the calendar buttons and fill out the number of incidents in each category: