BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEYER-SCHULTE H.C. DOUBLE LUMEN BREAST IMPLANT

    MDR report key: 10556 · Received December 17, 1993

    Report

    Report Number
    MW1000133
    Event Type
    Malfunction
    Date Received
    December 17, 1993
    Report Date
    December 6, 1993
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANTS: FRACTURES, LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE H.C. DOUBLE LUMEN BREAST IMPLANT DOUBLE LUMEN BREAST IMPLANTS FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. COMBO GREZ INFLAT/3100 ROUND 117219

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR