BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUTTA-PERCHA PLUGGER

    MDR report key: 6408973 · Received March 16, 2017

    Report

    Report Number
    8031010-2017-00009
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Report Date
    February 24, 2017
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    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, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PLUGGER BROKE DURING USE; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192473 GUTTA-PERCHA PLUGGER PLUGGER, ROOT CANAL, ENDODONTIC EKR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1