BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HENRY SCHEIN

    MDR report key: 20006488 · Received August 20, 2024

    Report

    Report Number
    3010364969-2024-00015
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 19, 2024
    Manufacturer
    TTBIO CORP.
    Product Code
    ELC
    UDI-DI
    00304040165126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DOCTORS HAND WAS BURNED DURING USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353750 HENRY SCHEIN INSERT ELC TTBIO CORP. ACCLEAN EASY GRIP XL TRIPLE BEND SLIM #1000 30K 00304040165126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other