BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAQTA ADULT SINGLE DOSE 50U/ML, MERCK

    MDR report key: 1040902 · Received May 12, 2008

    Report

    Report Number
    MW5006820
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 25, 2008
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING ADMINISTRATION, VAQTA AUTO INJECTOR SYRINGE MALFUNCTIONED AND NEEDLE DETACHED AND REMAINED IN PATIENT'S ARM. DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAQTA ADULT SINGLE DOSE 50U/ML, MERCK FMF 0926U

    Patients

    Seq Age Sex Outcome Treatment
    1