BEUDAMED
    FDA Adverse Event Summary report: N

    THERMAFIL ENDODONTIC OBTURATOR

    MDR report key: 11687 · Received February 10, 1994

    Report

    Report Number
    MW4000297
    Date Received
    February 10, 1994
    Report Date
    December 30, 1993
    Manufacturer
    TULSA DENTAL PRODUCTS
    Product Code
    EKQ
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS USED IN ROOT CANALS. AFTER HAVING THIS DEVICE INSERTED DURING ROOT CANAL PROCEDURE, CLIENT CONTINUED TO HAVE PROBLEMS. CLIENT EVENTUALLY HAD TO HAVE THE TOOTH REMOVED. THERE IS ALSO ANOTHER PERSON THAT THIS ATTY IS AWARE OF WHO HAD SIMILAR PROBLEMS. NO ONE IS SURE WHAT THIS DEVICE DOES. ENDODONTISTS DON'T USE IT. ATTY WOULD LIKE TO KNOW IF THIS DEVICE IS APPROVED BY THE FDA AND THE STATUS OF THIS DEVICE SINCE THERE ARE SOME LAWSUITS FILED AGAINST THIS FIRM PERTAINING TO THIS DEVICE. NO OTHER DENTAL PRODUCT OF THIS TYPE CONTAINS A METAL ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAFIL ENDODONTIC OBTURATOR EKQ TULSA DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 *