BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLEAN ULTRASONIC SCALER

    MDR report key: 16588533 · Received March 21, 2023

    Report

    Report Number
    3007007357-2023-00002
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 21, 2023
    Manufacturer
    TTBIO CORP
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING A ROUTINE PROPHY WITH SOME SCALING AND CAVITRON USE, THE BLACK HANDPIECE WHERE THE CAVITRON TIP IS INSERTED CAUSED A PIZZA LIKE BURN TO THE RIGHT INSIDE PART OF PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937047 ACCLEAN ULTRASONIC SCALER HANDPIECE EFB TTBIO CORP ACCLEAN ULTRASONIC SCALER

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other