BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT PLUS FORCEPS

    MDR report key: 3906554 · Received June 10, 2014

    Report

    Report Number
    2515379-2014-00035
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DENTSPLY CAULK
    Product Code
    DZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IS WAS REPORTED THAT A PAIR OF PALODENT PLUS FORCEPS BROKE; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338857 PALODENT PLUS FORCEPS DENTAL HAND INSTRUMENT DZN DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1