BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 642

    MDR report key: 3977474 · Received July 30, 2014

    Report

    Report Number
    MW5037554
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    January 24, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MICRO-MEGA SA-5
    Product Code
    EKS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MICRO-MEGA HAS BEEN INFORMED ABOUT AN ADVERSE EVENT. DURING AN ENDODONTIC TREATMENT (PULPECTOMY), THE BLADE OF THE ROTARY INSTRUMENT HAS BEEN ASPIRATED INSIDE THE ROOT CANAL. THE PLASTIC SHANK AND THE BLADE HAVE BEEN SEPARATED. THE DENTIST HAS NOT BEEN ABLE TO REMOVE THE BLADE OF THE TEETH AND THE TEETH HAS BEEN EXTRACTED. THIS EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444410 HERO 642 HERO 642 N 30 6 PERCENT L21 EKS MICRO-MEGA SA-5 20136012 030705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention