BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING

    MDR report key: 289661 · Received July 25, 2000

    Report

    Report Number
    MW1019570
    Event Type
    Injury
    Date Received
    July 25, 2000
    Date of Event
    December 31, 1993
    Report Date
    June 19, 2000
    Manufacturer
    DOW CORNING
    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 DYPHASIA AND FH BREAST CA W/ IMMEDIATE RECONSTRUCTION USING SQ 340:20CC DC BILUMENS (KENALOG IN SALINE). DEVELOPED INFECTION POST-OP IN L BREAST NECESSITATING REMOVAL 1 MO LATER AND ALSO DEVELOPED CONTRACTURE ON R W/ DELAYED HEMATOMA. HAD EVACUATION OF HEMATOMA, RELEASE OF CONTRACTURE AND REPLACEMENT W/ B 340CC DC GELS BUT CONTRACTURE REOCCURRED ON R & HAD SUBPECTORAL PLACEMENT W/ CAPSULX (NEAR TOTAL L, TOTAL ON R) & REPLACEMENT W/ 650CC SURGITEK GELS. ASYM OCCURRED & HAD L CONTRACTURE, SO HAD OPEN CAPSULOTOMY W/ ADD'L 245CC DC GELS PLACED FOR ADDED VOLUME. HAD OPEN CAPSULX FOR B CONTRACTURE R>L W/ REPLACEMENT W/ 600CC POLYURETHANE GELS AND NEEDED IV ANTIBIOTICS FOR A FEW DAYS 2WKS LATER, SECONDARY TO INFECTION AND I & D. NO REMOVAL 1 WK LATER. HAD L OPEN CAPSULOTOMY AND REPLACEMENT W/ 700CC REPLICON ALONG W/ ABDOMINOPLASTY AND CHOLECYSTX. SINCE THEN PT C/O L SIDE CONTINUING TO DECREASE IN SIZE AND R MIGRATING TO AXILLA. DENIES TRAUMA TO CHEST BUT DOES C/O PAIN IN BREASTS B - NOT INCREASED ON ONE SIDE. ALSO C/O SYSTEMIC PROBS INCLUDING ARTHRALGIAS (+ AM STIFFNESS), MYALGIAS, DYSESTHESIAS/PARESTHESIAS, SPASMS, SWELLING, CHRONIC FATIGUE, SLEEP DISTURB., SWOLLEN GLANDS, LOW GRADE FEVERS, REC. INFECTIONS, HEADACHES, TMJD DIST., VISUAL PROBS., DIZZY SPELLS, MEMORY LOSS, RASHES, CP, COSTOCHONDRITIS, CHOKING SEN., HYPERTENSION, WGT GAIN, GI/GU DISTURB., AND EASY BRUISING. OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING GEL BREAST IMPLANTS FTR DOW CORNING UNK HH091176

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| S