BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ROUND HIGH PROFILE GEL

    MDR report key: 3231954 · Received July 1, 2013

    Report

    Report Number
    1645337-2013-00220
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    April 1, 2012
    Report Date
    June 28, 2013
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RUPTURE, BULGE UNDER HER LEFT BREAST, ADHESIONS, PSYCHOLOGICALLY AFFECTED. SHE HAS ALSO SUSTAINED SERIOUS PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297371 SMOOTH ROUND HIGH PROFILE GEL BREAST IMPLANT FTR MENTOR 6446441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention