BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT PLUS FORCEPS

    MDR report key: 6077934 · Received November 3, 2016

    Report

    Report Number
    2515379-2016-00025
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    January 18, 2017
    Manufacturer
    DENTSPLY CAULK
    Product Code
    DZN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TIP FROM LEFT ARM HAS BROKEN OFF. NO FURTHER DAMAGE SEEN. CLEANING METHOD USED ULTRASONIC. THIS MAY HAVE CAUSED THE BREAKAGE.

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED 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 EVALUATION, THOUGH HAS NOT BEEN RETURNED 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 PALODENT PLUS FORCEPS BROKE AT THE TIP; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728815 PALODENT PLUS FORCEPS INSTRUMENTS, DENTAL HAND DZN DENTSPLY CAULK NA A0315

    Patients

    Seq Age Sex Outcome Treatment
    1