BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    301 ELEV

    MDR report key: 2576108 · Received May 10, 2012

    Report

    Report Number
    2523190-2012-00048
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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

    DOCTOR REPORTED VIA PHONE THAT THE DEVICE TIP BROKE WHILE IN USE AND THEY REACTED IN TIME SO THE PT DID NOT SWALLOW OR ASPIRATE THE TIP, BUT HE SAYS THAT WAS CLOSE TO HAPPENING. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 301 ELEV M51 - GENERAL DENTISTRY EMJ INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1