BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 760715 · Received September 13, 2006

    Report

    Report Number
    MW1040429
    Event Type
    Injury
    Date Received
    September 13, 2006
    Date of Event
    August 14, 2006
    Report Date
    September 13, 2006
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SALINE IMPLANTS FROM BILATERAL MASTECTOMY RUPTURE. THIS HAS BEEN REPORTED TO MENTOR CORP AND THEY STATE IT'S BEEN FORWARDED TO YOU. IMPLANT #'S-REF 354-2915 LOT 221349. I FIND MENTOR RESPONSIBLE FOR THIS. THEY HAVE LIED ANND COVERED UP. IT'S OUTRAGEOUS AND UNACCEPTABLE. WHEN I ASKED ALL THE RIGHT QUESTIONS BEFORE MY IMPLANTS WENT IN, I WAS LIED TO AND AM FINDING THAT OUT NOW. MY DOCTOR STATES THAT MY IMPLANT HAD A WRINKLE AND RUBBED AND MADE A HOLE. WHEN ASKED ABOUT BREAKAGE BACK AT THE BEGINNING OF ALL THIS, HE SAID IT WOULD TAKE AN "ACT OF GOD OR A TERRIBLE CAR WRECK TO BUST THESE. MAYBE HE IS JUST AS UNIFORMED AS I WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE IMPLANTS FWM MENTOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R