BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 288738 · Received July 27, 2000

    Report

    Report Number
    MW1019452
    Event Type
    Death
    Date Received
    July 27, 2000
    Date of Event
    November 4, 1998
    Report Date
    July 11, 2000
    Manufacturer
    NA
    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

    STATUS POST BILATERAL SUBGLANDULAR INFRAMAMMARY GELS FOR AUGMENTATION ABOUT 22 YRS AGO. WAS TOLD BY MD PT HAD A LEFT RUPTURE. PRESENTS NO COMPLAINTS OF DECREASED SIZE, BREAST PAIN OR CHANGE IN SHAPE/TEXTURE. THEY HAVE ALWAYS BEEN HARD PER PT AND THERE IS NO HISTORY OF TRAUMA. PT HAS SYSTEMIC SYMPTOMS FOR YRS INCLUDING ARTHRALGIAS (POSITIVE AM STIFFNESS), PARESTHESIAS RIGHT GREATER THAN LEFT, FATIGUE, SLEEP DISTURBANCE, MEMORY LOSS, DEPRESSION, PANIC ATTACKS, HAIR LOSS, RASH STATUS POST SUN, SUN SENSITIVITY, SHORTNESS OF BREATH, INCREASED BLOOD PRESSURE AND SCIATICA. THE PT IS OTHERWISE HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA GEL BREAST IMPLANTS FTR NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| S