7 Single Entity Combination Product Case Processing

These are the steps for creating/processing cases with Single entity Combination Products:

1. Book-in a Case with information received as per Source documents.
   If the Suspect Product involved is a Combination Product, on product selection from the Product browser, system activates the Vaccine and Device tabs.
2. Enter the Vaccine and Device data in the corresponding tabs.
3. Select Combination Product in the General > Case Classification field.
4. Save the case and ensure that all mandatory data required for the CBER submission is entered.
5. Perform Auto-scheduling and the system schedules an eVAERS report to the CBER agency using the eVAERS Profile.
6. Click the Draft link to preview the report in XML view.

The <combinationproductreport> element is populated with the true value indicating ICSR contains Combination Product.

The <localcriteriareportype> element is populated with one of these values below indicating the report type:

• 1 = 15-day
• 2 = Non-Expedited
• 4 = 5-day
• 5 = Malfunction Only (No AE)

The Device data is embedded within the <drug> block pertaining to the Primary mode of action product as below:

<drug>
<drugcharacterization>1</drugcharacterization>
<medicinalproduct>Tetanus</medicinalproduct>
<obtaindrugcountry>US</obtaindrugcountry>
<deviceinfo>
<malfunction>true</malfunction>
<brandname>Tetanus</brandname>
<commondevicename>Piston Syringe </commondevicename>
<typeoffollowup>
<followuptype>1</followuptype>
</typeoffollowup>
<deviceproblem>
<deviceproblemcode>1095</deviceproblemcode>
</deviceproblem>
<manufacturer>
<manufacturername>Aster Inc</manufacturername>
<manufacturercity>Bridgewater</manufacturercity>
<manufacturerstate>NJ</manufacturerstate>
<manufacturercountry>US</manufacturercountry>
</manufacturer>
<remedialaction>
<remedialactioninitiated>5</remedialactioninitiated>
</remedialaction>
</deviceinfo>
</drug>