BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HENRY SCHEIN

    MDR report key: 19848724 · Received July 28, 2024

    Report

    Report Number
    3010364969-2024-00014
    Event Type
    Malfunction
    Date Received
    July 28, 2024
    Report Date
    July 29, 2024
    Manufacturer
    TTBIO CORP.
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    TIP BROKE OFF DEVICE DURING TREATMENT OF PATIENT. THE PATIENT EXPERIENCED MINOR CHEEK BLEEDING AS A RESULT. NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036680 HENRY SCHEIN HANDPIECE EGS TTBIO CORP. MASTER TORQUE 3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other