BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOM IMPLANT

    MDR report key: 2982675 · Received February 21, 2013

    Report

    Report Number
    MW5029136
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    November 11, 2012
    Report Date
    February 21, 2013
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    NXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE DEVELOPED A SKIN RASH ON MY EYELIDS AND LEGS. I HAVE DIFFICULTY TAKING A HOT SHOWER SINCE I HAD MY MOM IMPLANT PLACED IN MY R HIP. MY EYES ARE TOO SENSITIVE TO WARM WATER. I HAVE TO USE EYE DROPS TO CONTROL MY RASH AND ITCHING IN MY EYES. MY EYESIGHT HAS ALSO DRASTICALLY DIMINISHED OVER THE PAST YR. MY HEARING HAS ALSO BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77214 MOM IMPLANT BIRMINGHAM RESURFACING NXT SMITH AND NEPHEW NOT SURE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other