BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 290848 · Received July 25, 2000

    Report

    Report Number
    MW1019621
    Event Type
    Injury
    Date Received
    July 25, 2000
    Date of Event
    August 30, 1996
    Report Date
    June 14, 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 SQ MASTX'S FOR FCD WITH APPARENT IMMEDIATE SUBMUSC BILUMEN SURGITEK RECONSTRUCTIONS. DUE TO DECREASED R SIDE UNDERWENT B OPEN CAPSULOTOMIES, REMOVALS R RUPTURED WITH L DEFLATED AND REPLACEMENT WITH 285.80 BILUMEN SURGITEKS. INCREASED PAIN, SEVERE ON L X 1 YRS. NO H/O TRAUMA. IN ADDITION, HAS DEVELOPED SYSTEMIC SX'S OVER THE LAST FEW YRS WHICH ARE PROGRESSIVE AND DISABLING. THESE INCLUDE ARTHRALIGAS (+ AM STIFFNESS L MORE THAN G/MYALGIAS, PARESTHESIAS/DYSESTHESIAS, SPASMS, SWELLING, FATIGUE, SLEEP DISTURB, SQ LUMPS ADENOPATHY, HOT FLASHES/DRENCHING SWEATS, REC URIS, HEADACHES, TMJD, VISUAL CHANGES, DIZZINESS, MEMORY LOSS, SICCA, HAIR LOSS, RASHES, SENS SUN/COLD (+ RAYNAUD'S)/CHEM, SOB/CP, COSTOCHONDRITIS, CHOKING SENS, SKIN TIGHTENING, LABILE BP, INCREASED CHOLESTEROL, WGT GAIN,GI/GU DISTURB, DECREASED NAIL GROWTH WITH NAIL FUNGUS. OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK GEL BREAST IMPLANTS (SALINE) FTR SURGITEK UNK 23583-87E, 22111-87E

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| S