BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 519946 · Received March 30, 2004

    Report

    Report Number
    MW1031690
    Event Type
    Injury
    Date Received
    March 30, 2004
    Date of Event
    January 1, 1997
    Report Date
    March 30, 2004
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS JUST HAD 3RD SURGERY TO REMOVE MENTOR BREAST IMPLANTS DUE TO RUPTURE AND DEFLATION AND BREAST PAIN. HAS SENT LAST TWO TO A LAB THEMSELVES. THE IMPLANTS WERE COMPLETELY FLAT. THE OTHER MENTOR IMPLANTS WERE SENT TO MENTOR AND RESULTS WERE GIVEN TO PHYSICIAN AND TEARS IN DEVICE WERE THE PROBLEM. PT ANGRY AND UPSET AND STATES MENTOR CUSTOMER SERVICE WAS RUDE AND UNHELPFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE/SILICONE SHELL BREAST IMPLANT (BIL) FWM MENTOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR