BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE FILLED BREAST IMPLANT

    MDR report key: 1133455 · Received August 22, 2008

    Report

    Report Number
    1133455
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MCGHAN
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEFLATED RIGHT BREAST. BREAST IMPLANT EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FILLED BREAST IMPLANT BREAST IMPLANTS FWM MCGHAN REF. 25-68331 612036

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization