BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 296320 · Received September 13, 2000

    Report

    Report Number
    MW1019905
    Event Type
    Injury
    Date Received
    September 13, 2000
    Date of Event
    June 23, 2000
    Report Date
    September 5, 2000
    Manufacturer
    SURGITEK
    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 SUBGLAND INFRA 255CC SURGITEK GELS FOR AUGMENTATION." "C/O LT IS FIRMER AND RT IS LOWER AND SOFTER. SINCE TENNIS INJURY TO RT SIDE (LEFT BRUISED) IN 1991. HAS NO PAIN IN BREAST BUT HAS DEVELOPED PROGRESSIVELY DISABLING SYSTEMIC SX'S SIX 1992. THESE INCLUDE ARTHRALGIAS/MYALGIAS (PLUS AM STIFFNESS), PARESTHESIAS, SPASMS, SWELLING, FATIGUE, SLEEP DISTURB, ADENOPATHY, HOT FLASHES/SWEATS, HEADACHES, DENTAL PROBS, VISUAL CHANGES, DIZZINESS, MEMORY LOSS, SEVERE SICCA, RASHES, ORAL SORES, HAIR LOSS, SENS SUN/CHEM/SOB, CHOKING SENS, HYPOTHYROIDISM, INCREASED CHOLESTEROL, WGT GAIN, GI/GU DISTURB, AND EASY BRUISING. PT IS OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK GEL BREAST IMPLANTS FTR SURGITEK 13.1 - SIZE 00285-84-C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| S