BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK IPI

    MDR report key: 2601625 · Received May 31, 2012

    Report

    Report Number
    MW5025653
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 31, 2012
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD TMJ VITEK IPI IMPLANTED ON LEFT SIDE IN 1982 AND HAS NOT HAD ANY SURGERIES SINCE. PT WAS INFORMED OF THE VITEK RECALL ABOUT 8-10 YEARS AGO HER GENERAL DENTIST. PT IS NOW EXPERIENCING MAJOR MEDICAL ISSUES: PAIN ON LEFT SIDE, RESPIRATORY, SINUS, HEADACHES, EYE RUNS, FLUID IN EARS, TEETH PROBLEMS ON LEFT SIDE, COLD/HOT SENSITIVITIES, FEELS SPACEY, AND HAS BALANCE ISSUES. PT IS NOW LOOKING AT OPTIONS AS TO HOW TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK IPI VITEK IPI LZD VITEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R| S