9 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 selection of the Product from Product browser, the system enables Drug and Device tabs.
2. Enter Drug and Device data in the corresponding tabs.
3. Select Combination Product in the General > Case Classification field.
4. Save the case and ensure all the mandatory data is entered that is required for CDER submission.
5. Perform Auto-scheduling and system schedules an E2B report to CDER agency using FDA 2.2 DTD Profile.
6. Click the Draft link to preview the report in XML view.
7. The <combinationproductreport> element is populated with value 1 indicating ICSR contains Combination Product.
8. The <fulfillexpeditedcriteria> element is populated with one of these values below indicating the type of report:
   • 1 = 15-day
   • 2 = Non-Expedited
   • 4 = 5-day
   • 5 = Malfunction (30-day)

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

   <drug>
   <drugcharacterization>1</drugcharacterization>
   <medicinalproduct>ADYPHREN</medicinalproduct>
   <obtaindrugcountry>US</obtaindrugcountry>
   <expirationdateformat>102</expirationdateformat>
   <expirationdate>20190201</expirationdate>
   <productavailableforevaluation>2</productavailableforevaluation>
   <productreturndateformat>610</productreturndateformat>
   <productreturndate>201804</productreturndate>
   <brandname> ADYPHREN</brandname>
   <commondevicename>Convenience Kit</commondevicename>
   <productcode>006</productcode>
   <modelnumber>Model1234567</modelnumber>
   <catalognumber>CatalogABCD1234</catalognumber>
   <serialnumber>SerialNumber1234</serialnumber>
   <udinumber>UDI1234</udinumber>
   <dateimplantedformat>102</dateimplantedformat>
   <dateimplanted>20180201</dateimplanted>
   <dateexplantedformat>102</dateexplantedformat>
   <dateexplanted>20180201</dateexplanted>
   <deviceage>2</deviceage>
   <deviceageunit>801</deviceageunit>
   <labeledsingleusedevice>1</labeledsingleusedevice>
   <devicemanufacturedateformat>102</devicemanufacturedateformat>
   <devicemanufacturedate>20180201</devicemanufacturedate>
   <remedialactionrecall>1</remedialactionrecall>
   <remedialactionrepair>2</remedialactionrepair>
   <remedialactionreplace>1</remedialactionreplace>
   <remedialactionrelabel>2</remedialactionrelabel>
   <remedialactionnotify>1</remedialactionnotify>
   <remedialactioninspection>2</remedialactioninspection>
   <remedialactionpatientmonitor>1</remedialactionpatientmonitor>
   <remedialactionmodifyadjust>2</remedialactionmodifyadjust>
   <remedialactionother>1</remedialactionother>
   <deviceusage>2</deviceusage>
   <devicelotnumber>DevLot1234</devicelotnumber>
   <malfunction>1</malfunction>
   <followupcorrection>1</followupcorrection>
   <followupadditionalinfo>2</followupadditionalinfo>
   <followupresponsetofda>1</followupresponsetofda>
   <followupdeviceevaluation>1</followupdeviceevaluation>
   <operatorofdevice>Lay User</operatorofdevice>
   <manufacturer>
   <manufacturername>Aster Devices Inc</manufacturername>
   <manufactureraddress>11 Crown Towers</manufactureraddress>
   <manufacturercity>Bridgewater</manufacturercity>
   <manufacturerstate>NY</manufacturerstate>
   <manufacturercountry>US</manufacturercountry> </manufacturer>
   <deviceproblemandevaluation>
   <evaluationtype>01</evaluationtype>
   <evaluationvalue>1396</evaluationvalue> </deviceproblemandevaluation>
   </drug>