BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWO STRIPPER INTERPROXIMAL DENTAL BUR

    MDR report key: 15224314 · Received August 12, 2022

    Report

    Report Number
    MW5111465
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    August 10, 2022
    Report Date
    August 11, 2022
    Manufacturer
    TWO STRIPPER / ABRASIVE TECHNOLOGY, LLC.
    Product Code
    DZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTERPROXIMAL CROWN BURR TIP FOUND TO HAVE BROKEN WHILE BEING USED FOR PATIENT CARE, 2 VIEW CHEST X RAY COMPLETED TO RULE OUT ASPIRATION. ISODRY SYSTEM WAS IN PLACE DURING THE PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2848437 TWO STRIPPER INTERPROXIMAL DENTAL BUR INSTRUMENT, DIAMOND, DENTAL DZP TWO STRIPPER / ABRASIVE TECHNOLOGY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Other