BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 5253925 · Received November 23, 2015

    Report

    Report Number
    MW5058159
    Event Type
    Injury
    Date Received
    November 23, 2015
    Report Date
    November 23, 2015
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY MENTOR SALINE IMPLANTS CAUSED TREMENDOUS HARM PHYSICALLY AND LOSS OF QUALITY OF LIFE. I HAVE DEBILITATING PAIN. CONTACTED MY PS TODAY. TOLD THE OFFICE I HAVE RUPTURE AND PAIN. THEY ARE NOT ABLE TO SEE ME TIL (B)(6) 2015, TODAY IS (B)(6). RIDICULOUS, CANT FIND A SURGEON IN MY CITY TO TAKE THEM OUT AS I CONTINUE TO GET MORE ILL. I NEED EN BLOC WITH TOTAL CAPSULECTOMY. MY IMPLANTING SURGEON DOESN'T CARE. I AM IN PAIN AND HARM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772448 BREAST IMPLANT BREAST IMPLANT FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other