BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 17613304 · Received August 24, 2023

    Report

    Report Number
    3007007357-2023-00008
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 24, 2023
    Manufacturer
    TTBIO CORP
    Product Code
    EFB
    UDI-DI
    00304040126424
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    HEAD PART OF DEVICE FELL APART INTO PATIENT'S MOUTH DURING REMOVAL OF DECAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090340 HENRY SCHEIN HANDPIECE EFB TTBIO CORP PRO 2-N SLIDE LATCH HEAD 00304040126424

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other