BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRROR - DBL SIDED, SZ 4

    MDR report key: 2440442 · Received January 19, 2012

    Report

    Report Number
    2523190-2012-00012
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    INTEGRA YORK, PAINC.
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FOLLOWING A ROUTINE DENTAL CLEANING, THE PT SAID IT FELT LIKE THERE WAS SOMETHING LOOSE IN HIS MOUTH. HE PULLED OUT THE DENTAL MIRROR. THERE WAS NO PT 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, PAINC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR