BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT PLUS FORCEPS

    MDR report key: 5100625 · Received September 24, 2015

    Report

    Report Number
    2515379-2015-00057
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 26, 2015
    Manufacturer
    DENTSPLY CAULK
    Product Code
    DZN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    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 MANUFACTURER TO CORRECT THIS ISSUE.

    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
    633097 PALODENT PLUS FORCEPS INSTRUMENTS, DENTAL HAND DZN DENTSPLY CAULK D0612

    Patients

    Seq Age Sex Outcome Treatment
    1