BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANT

    MDR report key: 289633 · Received July 27, 2000

    Report

    Report Number
    MW1019560
    Event Type
    Injury
    Date Received
    July 27, 2000
    Report Date
    April 22, 1998
    Manufacturer
    SILASTIC
    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 R MRM FOR STAGE I BREAST CA. L SQ MARTX AND & B 235CC SILASTIC GELS FOR RECONSTRUCTION. L WAS THIN MUSCLE. SCAR REVISIONS AND EXCISION EXCESS SKIN ON L, C/O DECREASED SIZE OF BREASTS, NO H/O TRAUMA. RECONSTRUCTION R>L, FOUND ON MRI B RUPTURE. ARTHRALGIAS (+ AM STIFFNESS), MYALGIAS, DYSESTHESIAS/PARESTHESIAS, SPASMS, SWELLING, FATIGUE, SLEEP DISTURB., FREQUENT URI'S, FEVERS, HOT FLASHES/CHILLS/DRENCHING SWEATS, HEADACHES, DENTAL PROBS., VISUAL DISTURB., MEMORY LOSS, HAIR LOSS, ORAL SORES, RASHES, SENS. SUN/COLD, SOB/CP, COSTOCHONDRITIS, HTN, WGT. GAIN, GU DISTURB., AND EASY BRUISING. L RUPTURED BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANT 235CC FTR SILASTIC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| S