BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMA PRO 2

    MDR report key: 14164563 · Received April 20, 2022

    Report

    Report Number
    3007007357-2022-00004
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 20, 2022
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    DENTIST USED TWO NEW HANDPIECES DURING NORMAL COMPOSITE FILLING PROCEDURES WITH TWO DIFFERENT PATIENTS. ONE FEMALE PATIENT RECEIVED MINOR LACERATION IN THE MOUTH DURING A PROCEDURE, DUE TO A BUR THAT WAS COMING OUT OF THE HANDPIECE. NO SPECIFICATIONS OF THE BUR COULD BE PROVIDED BUT THE OFFICE DID INDICATE THAT IT WAS AN SS WHITE BUR. DENTIST APPLIED ON SOME ANTISEPTIC ON THE SMALL LACERATION RECEIVED. MALE PATIENT ALMOST SWALLOWED THE SAME TYPE OF BUR BUT DENTIST WAS ABLE TO BE RETRIEVE WITH NO PATIENT HARM. OFFICE INDICATED THAT THEY UNABLE TO DETERMINE WHICH SERIAL NUMBER HANDPIECE WAS WITH WHAT PATIENT. THE BURS WERE COMING OUT FAIRLY EASY FOR NEW HANDPIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771900 MAXIMA PRO 2 HANDPIECE EFB TTBIO CORP. MAXIMA PRO 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other