BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGITEK BILUMEN SALINE/GEL

    MDR report key: 560690 · Received October 14, 2004

    Report

    Report Number
    MW1033730
    Event Type
    Malfunction
    Date Received
    October 14, 2004
    Date of Event
    July 21, 2004
    Report Date
    July 21, 2004
    Manufacturer
    SURGITEK
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BREAST PTOSIS WITH DISPLACEMENT OF GEL IMPLANTS. REMOVE NAD REPLACE GEL BREAST IMPLANTS WITH GEL IMPLANTS. LEFT INTACT WITH CAPSULECTOMY. CAPSULE MODERATELY THICKENED. MINIMAL CALCIFICATIONS. RIGHT GEL EXPLANT. OUTER LUMEN SALINE RUPTURE, MINIMAL GEL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK BILUMEN SALINE/GEL BILUMEN GEL/SALINE FTR SURGITEK (L) LM02038-02 88521-89K
    2 SURGITEK BILUMEN SALINE/GEL BILUMEN GEL/SALINE FTR SURGITEK (L) LM02038-02 79946-89I
    3 SURGITEK BILUMEN SALINE/GEL BILUMEN GEL/SALINE FTR SURGITEK (L) LM02038-02 88521-89K

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other BENELLI MASTOPEXY