BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENTULO PASTE CARRIER

    MDR report key: 4231577 · Received October 18, 2014

    Report

    Report Number
    8031010-2014-00009
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Report Date
    September 16, 2014
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    DZA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR 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 LENTULO SEPARATED, SEPARATED PIECE WAS INCORPORATED INTO THE FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663822 LENTULO PASTE CARRIER DRILL, DENTAL, INTRAORAL DZA DENTSPLY MAILLEFER 8131200

    Patients

    Seq Age Sex Outcome Treatment
    1