BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT PLUS FORCEPS

    MDR report key: 4943591 · Received July 23, 2015

    Report

    Report Number
    2515379-2015-00048
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Report Date
    June 23, 2015
    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

    THE ACTUAL DEVICE WAS NOT INVESTIGATED BECAUSE THIS FAILURE IS A KNOWN ISSUE. A CAPA WAS INITIATED FOR TIP BREAKAGE FOR THIS BATCH AND INVESTIGATION SHOWED THAT THE FAILURES FOR THIS LOT MAY BE RELATED TO THE SUPPLIER'S MANUFACTURING PROCESS. A SCAR HAS BEEN ISSUED TO THE SUPPLIER TO FURTHER INVESTIGATE THE ISSUE.

    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 21CFR 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
    480687 PALODENT PLUS FORCEPS DENTAL HAND INSTRUMENT DZN DENTSPLY CAULK A1213

    Patients

    Seq Age Sex Outcome Treatment
    1