BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIODENT FORCEPS

    MDR report key: 3788484 · Received April 3, 2014

    Report

    Report Number
    3003959465-2014-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 4, 2014
    Manufacturer
    DENTSPLY (N.Z.) LIMITED
    Product Code
    DZN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS WHERE THIS MALFUNCTION WITH A SIMILAR DEVICE RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PAIR OF TRIODENT FORCEPS BROKE; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202195 TRIODENT FORCEPS DENTAL HAND INSTRUMENT DZN DENTSPLY (N.Z.) LIMITED 011609

    Patients

    Seq Age Sex Outcome Treatment
    1