1. CDRH eMDR Best Practices
  2. How to create and process cases with Device Products

6 How to create and process cases with Device Products

Steps for creating and processing cases with Device Products

Follow these steps to create and process cases with Device Products when generating an eMDR:
  1. Book-in a case with the information received as per the source documents.

    Note:

    When you select the product from the Product browser, the Device tabs are enabled if the suspect product involved is a device product.
  2. Enter Device data. You can also enter additional device information in the MedWatch information pop-up window within the Device tab.
  3. You can select:
    • IMDRF Codes that refer to the Device Problem code, evaluation Codes from the Device tab.
    • IMDRF Codes pertaining to Patient Problem codes from the Events tab > Clinical Signs IMDRF Code.
  4. If the administered product was a Combination Product, enter the Drug information as a separate product in the case and then enter data in the Drug tab.
  5. Save the case. Make sure all mandatory information required for CDRH submission is entered.
  6. Perform auto-scheduling. The system schedules an eMDR to the CDRH agency by using the eMDR Profile.
  7. Click the Draft link to preview the report in XML view.
  8. The Device data is embedded within the <suspectdevice> block as seen below:
     <suspectdevice>
  <brandname>PaceM</brandname> 
  <typeofdevicename>Heart Pacemaker</typeofdevicename> 
  <typeofdevicecode>OSR</typeofdevicecode> 
  <singleusereprocorreuse>true</singleusereprocorreuse> 
 <devicemfrinfo>
  <mfrname>Aster Inc</mfrname> 
  <mfraddressline1>#4, Presto Avenue</mfraddressline1> 
  <mftcity>Irvine</mftcity> 
  <mfrcountry>USA</mfrcountry> 
  <mfrpostalcode>787938794</mfrpostalcode> 
  <mfremail>mailto:Test@test.com</mfremail> 
  </devicemfrinfo>
  </suspectdevice>
  9. The Drug data is embedded within the <suspectproducts> block as seen below:
    <suspectproducts>
  <drugseqnum>1</drugseqnum> 
  <drugname>Drug-A </drugname> 
  <manufacturername>Aster Inc</manufacturername> 
  <drugbatchnumb>B30475</drugbatchnumb> 
  <drugstructuredosagenumb>3</drugstructuredosagenumb> 
  <drugstructuredosageunit>012</drugstructuredosageunit> 
  <drugadministrationroutetext>003</drugadministrationroutetext> 
  <drugstartdate>20200420</drugstartdate> 
  <diagnosisuse>Injection(Injection)</diagnosisuse> 
  <compoundedproduct>false</compoundedproduct> 
  <otcproduct>false</otcproduct> 
  </suspectproducts>