BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 CS MIRR. FS DOUBLE SIDE

    MDR report key: 2180778 · Received July 7, 2011

    Report

    Report Number
    2523190-2011-00049
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTAL HYGIENIST

    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

    FACILITY REPORTED THE MIRRORS ARE COMING APART. ON (B)(6) 2011, ADD'L INFO WAS PROVIDED BY THE DENTAL HYGIENIST WHO REPORTED SHE USED THE MIRROR TO PULL THE PT'S CHEEK BACK WHILE CLEANING THE PT'S TEETH AND THE MIRROR SLID OFF INTO THE PT'S MOUTH. SHE SAID SHE FELT THE ADHESIVE DID NOT HOLD THE MIRROR SECURELY. THERE WAS NO INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1