BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAT-CARRIER PLUGGER

    MDR report key: 6194388 · Received December 21, 2016

    Report

    Report Number
    8031010-2016-00112
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    December 21, 2016
    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

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE 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 21 CFR 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 HEAT CARRIER PLUGGER 1-2 BROKE DURING OPERATION; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842773 HEAT-CARRIER PLUGGER PLUGGER, ROOT CANAL, ENDODONTIC EKR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1