BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMAVEL DOSEPRO 6 MG

    MDR report key: 2089925 · Received May 11, 2011

    Report

    Report Number
    MW5020575
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ZOGENIX
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) - PT CAME IN WITH A MIGRAINE. ASKED TO BE GIVEN ABOVE PRODUCT. IT WAS PRIMED AND PLACED AGAINST THE SKIN. IT DID NOT ACTIVATE, SO IT WAS TRIED TWO MORE TIMES. AT THIS POINT, I PULLED IT AWAY FROM THE PT AND WITHIN 3 SECONDS, IT SELF-ACTUATED, FORCEFULLY DISCHARGING CONTENTS INTO THE AIR. IT DID NOT STRIKE THE PT OR MYSELF BUT WAS BETWEEN BOTH OF US AS IT WAS BEING MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMAVEL DOSEPRO 6 MG TRANSDERMAL KZE ZOGENIX 020688

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other