BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRROR - DBL SIDED, SZ 5

    MDR report key: 2505122 · Received March 21, 2012

    Report

    Report Number
    2523190-2012-00028
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS DISCARDED AND IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE DENTAL HYGIENIST REPORTED THE DEVICE CAME APART INSIDE A PT'S MOUTH AND WAS THROWN AWAY BY THE DR. THERE WAS NO INJURY REPORTED. THE MIRROR THAT FELL APART INSIDE A PT'S MOUTH WAS NOT AVAILABLE FOR INVESTIGATION. TWO ADD'L (SAME) DEVICE'S "STARTED TO LIFT" AND WERE PUT ON THE SHELF SO THEY WOULD NOT BE USED ON PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRROR - DBL SIDED, SZ 5 M52, HYGIENE/PERIODONTAL EAX INTEGRA YORK, PA INC

    Patients

    Seq Age Sex Outcome Treatment
    1