BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 1873784 · Received October 13, 2010

    Report

    Report Number
    MW5017725
    Event Type
    Injury
    Date Received
    October 13, 2010
    Report Date
    August 2, 2010
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEFLATION OF LEFT BREAST IMPLANT. REMOVAL OF DEFLATED SALINE IMPLANT AND SALINE IMPLANT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR BREAST IMPLANT SILTEX ROUND MODERATE PROFILE SALINE 350 ML FWM MENTOR 5788157

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization