BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 2171888 · Received September 8, 2006

    Report

    Report Number
    2171888
    Event Type
    Injury
    Date Received
    September 8, 2006
    Date of Event
    July 28, 2006
    Report Date
    August 2, 2006
    Manufacturer
    SURGITEK
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANT RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST IMPLANT FWM SURGITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention