BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPO-PROVERA¿ INJECTABLE SUSPENSION

    MDR report key: 1840812 · Received September 3, 2010

    Report

    Report Number
    1840812
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 15, 2010
    Report Date
    September 3, 2010
    Manufacturer
    TEVA PHARMACEUTICAL INDUSTRIES
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN GIVING THE INJECTION, THE NURSE PRIMED THE NEEDLE AND STUCK THE PATIENT'S ARM AND THE MEDICATION WOULD NOT GO THROUGH THE NEEDLE. HAD TO CHANGE NEEDLES AND RESTICK THE PATIENT. MEDICATION WAS ADMINISTERED WITHOUT PATIENT HARM.====================== HEALTH PROFESSIONAL'S IMPRESSION======================FAULTY DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPO-PROVERA¿ INJECTABLE SUSPENSION SYRINGE, DRUG FMF TEVA PHARMACEUTICAL INDUSTRIES * 31307507B

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR