BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALODENT PLUS FORCEPS

    MDR report key: 2928927 · Received January 16, 2013

    Report

    Report Number
    2515379-2013-00001
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 18, 2012
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EJG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVALUATION OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE THIS 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 BE LIKELY TO 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 EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE 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 DID NOT HAVE A GOOD GRIP ON A MATRIX RING AND AS A RESULT, THE RING "JUMPED OFF" THE FORCEPS AND CHIPPED THE TOOTH OF A PATIENT. IT IS UNKNOWN IF A RESTORATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24820 PALODENT PLUS FORCEPS EJG DENTSPLY CAULK D0711

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability MATRIX RING