BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRROR - DBL SIDED, SZ 4

    MDR report key: 2437929 · Received January 16, 2012

    Report

    Report Number
    2523190-2012-00010
    Event Type
    Malfunction
    Date Received
    January 16, 2012
    Report Date
    January 16, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE MIRROR SEEMED TO COME UNGLUED AND FELL INTO A PATIENT'S MOUTH. THE MIRROR WAS RETRIEVED AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRROR - DBL SIDED, SZ 4 M52 - HYGIENE/PERIODONTAL EAX INTEGRA YORK, PA INC. 02623

    Patients

    Seq Age Sex Outcome Treatment
    1