12 Similar Device Case Processing (Co-Packaged Combination Products)

These are the steps for creating/processing cases that have Non-US marketed device that involves reportable malfunction and similar devices marketed in the US as part of Co-packaged Combination Product:

1. Book-in a Case with information received as per Source documents.
2. If the Suspect Device had caused a reportable malfunction, then check the Product Portfolio for Similar devices marketed in the US as Combination Product.
3. If such product exists, then add the PMOA Product from the Product browser and enter the following data:
   1. Product type = Treatment / Other
   2. Drug not administered = Ticked
4. Add the Constituent Device Product from the Product browser and enter the following data:
   1. Product type = Treatment / Other
   2. Drug not administered = Ticked
   3. Similar Device = Ticked
5. Select Combination Product in the General > Case Classification field.
6. Save the case and ensure that all mandatory data required for CDER submission is entered.
7. Perform Auto-scheduling and system schedules an E2B report to CDER agency using the FDA 2.2 DTD Profile.
8. Click the Draft link to preview the report in XML view.
   1. The <fulfillexpeditedcriteria> element is populated with value 5 indicating a 30-day Malfunction Only report.
   2. The <combinationproductreport> element is populated with value 1 indicating that ICSR contains Combination Product.
   3. The <drugcharacterization> element is populated with value 5 indicating Similar Device.

   The Similar Device data is populated in ICSR as in the example below.

   <fulfillexpeditecriteria>5</fulfillexpeditecriteria>
   <combinationproductreport>1</combinationproductreport>
   <drug>
   <drugcharacterization>5</drugcharacterization>
   <medicinalproduct>ADYPHREN</medicinalproduct>
   <brandname> ADYPHREN</brandname>
   <commondevicename>Type 1: Convenience Kit of Co-Package</commondevicename>
   <productcode>006</productcode>
   </drug>