BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODEN PLUS FORCEPS

    MDR report key: 3916438 · Received May 22, 2014

    Report

    Report Number
    2515379-2014-00029
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 24, 2014
    Manufacturer
    DENTSPLY CAULK
    Product Code
    DZN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BO
    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. ELECTRICITY WAS SHUT DOWN / INTERRUPTED DURING THE ANNEALING PROCESS, DUE TO VERY HEAVY ELECTRIC LOAD SHADING DURING THAT TIME. A SCAR HAS BEEN ISSUED TO THE ORIGINAL MFR, WHO IS CURRENTLY WORKING TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305226 PALODEN PLUS FORCEPS DENTAL HAND INSTRUMENT DZN DENTSPLY CAULK 120926

    Patients

    Seq Age Sex Outcome Treatment
    1