BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANT

    MDR report key: 17618 · Received November 14, 1994

    Report

    Report Number
    MW1004008
    Event Type
    Injury
    Date Received
    November 14, 1994
    Date of Event
    January 1, 1963
    Report Date
    October 31, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SILICONE BREAST IMPLANT RUPTURES AND SUBSEQUENT ILLNESS, SYSTEMIC DISABILITY, CHRONIC PAIN, BURNING AND WEAKNESS OF EXTREMITIES, FTIGUE AND CHRONIC FEVERS. REMOVAL OF RUPTURED IMPLANTS RESULTING IN DEFORMITY AND PAIN IN BREASTS AND CHEST MUSCLES, CHRONIC RASHES AND LOSS OF SENSATION OF SKIN IN HANDS AND FEET, IMPAIRED MOBILITY AND JOINT PAINS, LOSS OF THYROID GLAND. EXTREME FATIGUE AND HEADACHES. (ALSO SEE 1004007.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANT Implant SILICONE GEL BREAST IMPLANT FTR MCGHAN MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R| S