BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBRONENDO

    MDR report key: 7996880 · Received October 23, 2018

    Report

    Report Number
    2016150-2018-00057
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Report Date
    July 27, 2018
    Manufacturer
    SYBRONENDO
    Product Code
    EKR
    PMA / PMN Number
    K031664
    Removal / Correction Number
    Z-0413-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO AGE, GENDER, ETHNICITY, AND RACE. DATE OF EVENT WAS NOT PROVIDED. FOLLOW UP ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, HOWEVER THERE WAS NO RESPONSE. THE PRODUCT HAS BEEN IDENTIFIED AS A POTENTIAL AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.

    Description of Event or Problem · 1

    AN ALLEGED COMPLAINT WAS REPORTED THAT THE BUCHANAN PLUGGER OVERHEATED THE GUTTA PERCHA AND IT GOT INTO THE NASAL CAVITY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834507 SYBRONENDO BUCHANAN HEAT PLUGGER EKR SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1