BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN

    MDR report key: 289268 · Received July 25, 2000

    Report

    Report Number
    MW1019531
    Event Type
    Injury
    Date Received
    July 25, 2000
    Date of Event
    February 21, 1994
    Report Date
    July 13, 2000
    Manufacturer
    MCGHAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "S/P B SUBGL INFRA MCGHAN BILUMEN 180:20CC FOR AUGMENTATION. PT REPORTS NOTICING BREASTS WERE SOFTER AND SMALLER ABOUT 3-4 YRS AGO AND RETURNED TO SURGEON WHO DID NOT FEEL THERE WAS ANY PROBLEM. PT DENIES H/O TRAUMA EXCEPT MVA (CRASH AT 30MPH, DRIVING, WEARING SEAT BELT, CUT CHIN BUT DOES NOT RECALL INJURY TO CHEST, 5 YRS AGO). PT REPORTS SOME BURNING PAIN LOQ X 4 YRS, PROGRESSIVE. ALSO, HAS SOME SYSTEMIC C/O'S INCLUDING ARTHRALGIAS, MYALGIAS, DYSESTHESIAS, PARESTHESIAS, SPASMS, CHRONIC FATIGUE, SWOLLEN GLANDS (EBV +), FEVERS, HEADACHES, TMJ PROBS, VISUAL DISTURB, DIZZY SPELLS, MEMORY PROBS, RASHES, SENS SUN/COLD/CHEM, GI/PELVIC PROBS, AND EASY BRUISING. PT IS OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN BILUMEN BREAST IMPLANTS FTR MCGHAN 76 CL8108

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| S