BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORPORATION

    MDR report key: 2639492 · Received June 26, 2012

    Report

    Report Number
    MW5025991
    Event Type
    Injury
    Date Received
    June 26, 2012
    Date of Event
    June 22, 2012
    Report Date
    June 26, 2012
    Manufacturer
    MENTOR WORLDWIDE
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SILENT RUPTURE OF MENTOR GEL BREAST IMPLANT. SURGICAL EXCHANGE OF A MENTOR CORP RUPTURED GEL BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORPORATION SMOOTH ROUND MODERATE PROFILE PLUS GEL BREAST IMPLANT FTR MENTOR WORLDWIDE MENTOR CORP 6424923-057

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other