BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILL MAMMARY IMPLANT, 500 CC

    MDR report key: 17586 · Received November 11, 1994

    Report

    Report Number
    MW1004004
    Event Type
    Injury
    Date Received
    November 11, 1994
    Date of Event
    September 30, 1991
    Report Date
    November 1, 1994
    Manufacturer
    MCGHAN MEDICAL, INC.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RPTR RECEIVED BREAST IMPLANTS ON 1/22/91 BECAUSE OF THE RISK OF CANCER. SHE HAD NUMEROUS CYSTS REMOVED. SEVEN MONTHS LATER SHE STARTED HAVING CHEST PAIN. HER IMPLANTS WERE HIGH AND UNDER HER ARMS. THE DR WENT IN ON 9/30/91 TO MOVE THEM DOWN. HER RIGHT IMPLANT WAS RUPTURED. HER IMPLANTS WERE REPLACED BY THE DR IN SURGERY, WITHOUT HER CONSENT. SHE HAD 300 CC BEFORE REPLACED WITH 500 CC IMPLANTS. IMMEDIATELY SHE STARTED HAVING PROBLEMS WITH DRAINAGE AND PAIN AROUND HER IMPLANTS. ON 11/6/91 SHE HAD THEM REMOVED IN EMERGENCY BECAUSE OF INFECTION. RPTR HAS ATYPICAL NEUROLOGICAL DISEASE SYNDROME, MIXED CONNECTIVE TISSUE DISEASE/OVERLAP SYNDROME, ATYPICAL CONNECTIVE DISEASE, NONSPECIFIC AUTOIMMUNE CONDITION, NUMEROUS TRIPS TO HOSPS FOR HEADACHES AND NUMBNESS OF HANDS AND ARMS, TWO SUICIDE ATTEMPTS. (ALSO SEE 1003992.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL-FILL MAMMARY IMPLANT, 500 CC Implant SILICONE IMPLANT FTR MCGHAN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| L| R| S