BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMAVEL DOSEPRO SD/IJ 0.5ML 1 - 6MG

    MDR report key: 2310315 · Received October 20, 2011

    Report

    Report Number
    MW5022809
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Date of Event
    August 1, 2011
    Report Date
    October 17, 2011
    Manufacturer
    ZOGENIX
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE STEPS TO ADMINISTER MEDICATION AND DOES NOT HEAR THE POPPING SOUND WHEN MEDICATION HAS BEEN ADMINISTERED, FOUR PENS ARE AFFECTED. HAS USED OTHER PENS WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMAVEL DOSEPRO SD/IJ 0.5ML 1 - 6MG PEN FMF ZOGENIX 010794

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other