BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 168 MAMM IMPLANTS

    MDR report key: 1309364 · Received February 6, 2009

    Report

    Report Number
    MW5009910
    Event Type
    Injury
    Date Received
    February 6, 2009
    Date of Event
    September 1, 2008
    Report Date
    February 6, 2009
    Manufacturer
    MCGHAN MED CORP
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SIXTEEN YEAR OLD IMPLANTS, MCGHAN SALINE WITH POLYURETHANE COVER. RIGHT SIDE RUPTURE WHILE DRIVING, CHEST CAVITY WALL EXTREME PAIN, UNABLE TO USE ARMS, UNABLE TO TALK, COMMUNICATE. AMBULANCED TO THE HOSPITAL. COGNITIVE PROBLEM, MEMORY ATTENTION, HEADACHE, SHORT OF BREATH, JOINT, MUSCLE ACHES, ABNORMAL HEART RATE, FLU LIKE FEELING, MUSCLE TREMORS, SHOULDER PAIN, STIFFNESS, RASH. THEY HAD TO KNOCK ME OUT. THEY FOUND NOTHING WRONG. TWO WEEKS LATER, I GET OUT OF BED, DR GIVES ME PAIN MEDS, IT HELPS A LITTLE. I AM UNABLE TO FUNCTION. OVERWHELMED WITH FATIGUE, PAIN, UNCLEAR THINKING, MY ARMS DON'T WANT TO DO ANYTHING BUT LAY DOWN, BENDING MAKES ME PASS OUT, 60% OF THE TIME I CANT WORK. I DON'T WANT TO BE HERE LIKE THIS ANYMORE. I NEED EXPENSIVE EXPLANT REMOVAL WITH MASTOPEXY BUT DON'T HAVE CREDIT TO BORROW THE MONEY TO HAVE IT DONE, AND THE GIRLS THAT HAVE EXPLANTED STILL HAVE SYMPTOMS. I CAN'T TYPE WELL OR READ WELL. I CAN'T GET MY PANTS UP OR WASH MY HAIR, PULL THE CLOTHES OUT OF THE WASHER WITHOUT HAVING AN EPISODE. I PASSOUT SOMETHING DOESN'T ADD UP. DOSE OR AMOUNT: 410 CC. DATES OF USE: 1992 - 2009. DIAGNOSIS OR REASON FOR USE: REPLACE HARMFUL SILICONE IMPLANTS WITH SALINE BY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 168 MAMM IMPLANTS SALINE FWM MCGHAN MED CORP 27-168391 FF3366
    2 STYLE 168 MAMM IMPLANTS SALINE FWM MCGHAN MED CORP 27-168391 FI3218

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R| S