BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANT

    MDR report key: 1151963 · Received September 5, 2008

    Report

    Report Number
    MW5008223
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPLANT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE BREAST IMPLANT FWM MENTOR STTLC 1600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S