BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CORPORATION WORLDWIDE

    MDR report key: 3042694 · Received April 3, 2013

    Report

    Report Number
    MW5029644
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MENTOR CORP, WORLDWIDE
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGICAL REMOVAL OF RUPTURED MEMORY GEL BREAST IMPLANT. PER ULTRASOUND, POSSIBLE RUPTURE GEL BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135991 MENTOR CORPORATION WORLDWIDE MENTOR SMOOTH GEL BREAST IMPLANT FTR MENTOR CORP, WORLDWIDE 350-5501BC 5-40447

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other