BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 19731536 · Received July 12, 2024

    Report

    Report Number
    3007007357-2024-00019
    Event Type
    Injury
    Date Received
    July 12, 2024
    Report Date
    July 11, 2024
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    UDI-DI
    00304040058534
    Adverse Event
    Yes
    Report Source
    Distributor 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
    2348163 HENRY SCHEIN HANDPIECE EFB TTBIO CORP. MASTER TORQUE 3 PB FD HEAD 00304040058534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other