BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 375636 · Received December 17, 2001

    Report

    Report Number
    MW4003178
    Event Type
    Malfunction
    Date Received
    December 17, 2001
    Date of Event
    December 14, 2000
    Report Date
    December 17, 2001
    Manufacturer
    MENTOR TEXAS, INC
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER HAD BREAST AUGMENTATION SURGERY (SECOND OPERATION; PREVIOUS OPERATION 10 YEARS EARLIER). CONSUMER IMMEDIATELY NOTED THAT BREASTS HAD NOT INCREASED IN SIZE AS REQUESTED, AND NOTICED A HOOK-SHAPED LUMP ON THE SIDE OF RIGHT BREAST. DR INFORMED CONSUMER TO CONTINUE MASSAGE THERAPY BUT STATED APPROX SIX MONTHS LATER THAT THE LUMP WAS 'DEFINITELY A DEFECT.' DR REFUSES TO EXPLANT/REPLACE IMPLANTS WITHOUT MONEY UP FRONT, AND RECORDS ON OPERATION ARE INCOMPLETE. COMPLAINANT ADVISED TO CONTACT STATE MEDICAL BOARD REGARDING COMPLAINTS AGAINST THE CONDUCT OF THE PHYSICIAN AND STAFF. COMPLAINANT HAS BEEN IN TOUCH WITH REP OF MENTOR CORP REGARDING CONCERNS. MENTOR HAS BEEN IN TOUCH WITH THE DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57129 MENTOR BREAST IMPLANT, ROUND, 450 CC FTR MENTOR TEXAS, INC 7000 206674

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO