BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROULTRA ENDO TIPS

    MDR report key: 725938 · Received June 8, 2006

    Report

    Report Number
    2029155-2006-00279
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Report Date
    May 9, 2006
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELC
    PMA / PMN Number
    K960885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS INCIDENT, A PROULTRA TIP #4 SEPARATED. THOUGH THERE IS NO INDICATION THAT PATIENT INJURY OCCURRED AS A RESULT, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION (THOUGH SUCH INTEREVENTION IS INADVISABLE PER EXPERT OPINION PROVIDED BY DR. THE DEVICE WAS RETURNED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. FURTHER INFORMATION PERTAINING TO THIS EVENT, INCLUDING EVALUATION RESULTS, WILL BE SUBMITTED AS IT BECOMES AVAILABLE. 510(K) # K960885.

    Description of Event or Problem · 1

    A PROULTRA ENDO TIP SEPARATED. OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROULTRA ENDO TIPS ELC ELC DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN