BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANTS

    MDR report key: 165596 · Received April 21, 1998

    Report

    Report Number
    MW1013671
    Event Type
    Injury
    Date Received
    April 21, 1998
    Report Date
    April 9, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP. HEYER SCHULTE
    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

    A 56 YR OLD FEMALE, G4P4, STATUS POST SUBGLANDULAR TRANSAXILLARY BILUMEN HEYER SCHULTE (200:25) PLACED FOR AUGMENTATION ON 07-06-84. DENIES DECREASE IN SIZE OR HISTORY OF TRAUMA UNTIL 6/13. REPORTS SOFTER BUT NO OTHER PROBLEMS SINCE, EXCEPT FOR ENDOMETRIAL CANCER AND HERNIATED DISCS WITH RADICULOPATHY. BILATERAL RUPTURED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANTS Implant 200:25 BILUMEN FTR BAXTER HEALTHCARE CORP. HEYER SCHULTE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| S