BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALODENT FORCEPS

    MDR report key: 3090341 · Received April 15, 2013

    Report

    Report Number
    2515379-2013-00013
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 26, 2013
    Manufacturer
    DENTSPLY CAULK
    Product Code
    DZN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVAL OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE THIS ISSUE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION WOULD LIKELY CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, 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 IT WAS REPORTED THAT A PAIR OF PALODENT FORCEPS BROKE DURING USE AND CHIPPED A PT'S TOOTH; THE DENTIST REPAIRED THE PT'S TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161708 PALODENT FORCEPS DZN DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention MATRIX RING