BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 20322335 · Received September 27, 2024

    Report

    Report Number
    3007007357-2024-00026
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 21, 2024
    Report Date
    October 28, 2024
    Manufacturer
    TTBIO CORP
    Product Code
    EFB
    UDI-DI
    00304040110881
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    HANDPIECE EXPLODED WHILE IT WAS BEING USED ON A PATIENT. NO PATIENT INJURY.

    Description of Event or Problem · 0

    HANDPIECE EXPLODED WHILE IT WAS BEING USED ON A PATIENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491319 HENRY SCHEIN HANDPIECE EFB TTBIO CORP MAXIMA PRO 2S MINI NON OPTIC 00304040110881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other