BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CORP

    MDR report key: 443455 · Received February 13, 2003

    Report

    Report Number
    443455
    Event Type
    Malfunction
    Date Received
    February 13, 2003
    Date of Event
    November 1, 2002
    Report Date
    February 12, 2003
    Manufacturer
    MENTOR CORPORATION
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSPITAL FOR REMOVAL AND REPLACEMENT OF LEFT BREAST IMPLANT SECONDARY TO SPONTANEOUS DEFLATION. PT'S LEFT BREAST IMPLANT WAS GIVEN TO MFR REP AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORP BREAST IMPLANTS FWM MENTOR CORPORATION UNK 166027 BOTH RIGHT & LEFT

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR