BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDROXYPROGESTERONE 150 MG

    MDR report key: 928495 · Received October 11, 2007

    Report

    Report Number
    MW5004102
    Event Type
    Malfunction
    Date Received
    October 11, 2007
    Date of Event
    October 8, 2007
    Report Date
    October 11, 2007
    Manufacturer
    SICOR PHARMACEUTICALS, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    IN 2007, MALFUNCTION OF THE MEDROXY PROGESTERONE. I PREPPED THE SITE AND INSERTED THE NEEDLE THAT CAME WITH THE KIT, WITHDREW AND NO MOVEMENT ATTEMPTED TO INJECT AGAIN NO MOVEMENT. I RE-ADJUSTED THE NEEDLE POSITION SLIGHTLY AND AGAIN ATTEMPTED TO WITHDRAW WITH SLIGHTLY MORE PRESSURE, NO MOVEMENT, 2ND ATTEMPT TO INJECT THIS ATTEMPT WAS SUCCESSFUL AND THE MEDICATION WAS INJECTED. DOSE OR AMOUNT: 150 MG. ROUTE: IM. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: BIRTH CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDROXYPROGESTERONE 150 MG BD SAFETY GLIDE NEEDLE & SYRINGE FMF SICOR PHARMACEUTICALS, INC. 0703-6811-21 078801

    Patients

    Seq Age Sex Outcome Treatment
    1 YR