BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN

    MDR report key: 1003964 · Received February 25, 2008

    Report

    Report Number
    MW5005692
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ALLERGAN
    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

    300 ML SILICONE FILLED BREAST IMPLANT WITH HOLE IN PRODUCT. WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN BREAST IMPLANTS FWM ALLERGAN 20-300

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability