BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL NEEDLE

    MDR report key: 1628661 · Received March 1, 2010

    Report

    Report Number
    MW5015042
    Event Type
    Death
    Date Received
    March 1, 2010
    Date of Event
    October 16, 2009
    Report Date
    March 1, 2010
    Manufacturer
    SURGICAL NEEDLE MANUFACTURER
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BODY TEMPERATURE ELEVATED, BLOOD PRESSURE ELEVATED, WENT UP AND THEN CAME DOWN. MUST KEEP TAKING CLONIDINE TO MAINTAIN BLOOD PRESSURE. BODY WEIGHT WENT UP TO 178 16'S AND THEN CAME DOWN TO 138 SLOWLY AFTER BEING PARALYZED BY VACCINE. LEFT MYSELF VERY TIRED FOR 6 MONTHS. LATER, SURVIVED THIS LOSING MY LIFE AFTER LOSS OF 8 TO TEN IMMUNE SYSTEMS. GUAIFENESIN LIQ. 100 MG/5'M 10 NDC (B) (4) EAR CLEANING OF WAX IN BOTH CARS LEFT ME DIZZY. DOSE OR AMOUNT: 0.5' M.L; FREQUENCY: SINGLE; ROUTE: #1 AND #2: NEEDLE. DATES OF USE: (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: SWINE FLU, H1N1, PNEUMONIA. EVENT ABATED AFTER STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? YES. (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL NEEDLE HYPERDERMIC NEEDLE FMI SURGICAL NEEDLE MANUFACTURER

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| L| O| S (B) (4), GLAXO SMITH KLINE| (B) (4), NEUMO VAX # 23