BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 CS MIRR. FS DOUBLE SIDE

    MDR report key: 2497206 · Received March 13, 2012

    Report

    Report Number
    2523190-2012-00024
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    DENTAL HYGIENIST

    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 DENTAL HYGIENIST REPORTED THE MIRROR FACE CAME UNGLUED FROM THE FRAME OF THE MIRROR AND FELL INTO THE PT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 CS MIRR. FS DOUBLE SIDE M52 - HYGIENE / PERIODONTAL EAX INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1