BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 157664 · Received March 18, 1997

    Report

    Report Number
    MW1013214
    Event Type
    Injury
    Date Received
    March 18, 1997
    Manufacturer
    DOW CORNING CORP.
    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

    RIGHT RUPTURE. A 51 YR OLD WHITE G2P2O2 FEMALE STATUS POST SUBGLANDULAR 220CC DOW CORNING GELS 3-29-83. 1988 HAD A RIGHT UPPER OUTER QUADRANT MASS WHICH WAS A GRANULOMA ON BIOPSY. RIGHT WAS REPLACED 4-10-89 WITH SURGITEK 220CC GEL. "LOCAL SYSTEMIC" COMPLAINTS 2-17-93. MRI RIGHT GRANULOMA 4-22-93. RUPTURED LEFT IMPLANT WITH MODERATE CLOUDY/YELLOW. NON-SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant GEL BREAST IMPLANT 200CC FTR DOW CORNING CORP. * H 069521

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| S