7 Single Entity Combination Product Case Processing
These are the steps for creating/processing cases with Single entity Combination Products:
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>
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<remedialaction>
<remedialactioninitiated>5</remedialactioninitiated>
</remedialaction>
</deviceinfo>
</drug>