BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HENRY SCHEIN

    MDR report key: 17639078 · Received August 28, 2023

    Report

    Report Number
    3010364969-2023-00003
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    July 21, 2023
    Report Date
    December 13, 2023
    Manufacturer
    TTBIO CORP.
    Product Code
    EGS
    UDI-DI
    00304040126424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

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

    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
    2082808 HENRY SCHEIN HANDPIECE EGS TTBIO CORP. PRO 2-N SLIDE LATCH HEAD 00304040126424

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other