BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL SILICONE BREAST IMPLANT

    MDR report key: 5375932 · Received January 19, 2016

    Report

    Report Number
    5375932
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    November 20, 2014
    Report Date
    November 17, 2015
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: RIGHT BREAST SILICONE IMPLANT RUPTURE. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: EXCHANGE OF RIGHT BREAST SILICONE IMPLANT. EXTENSIVE CAPSULOTOMIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35316 MENTOR MEMORYGEL SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR 3506504BC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1