BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSILLUMINATOR

    MDR report key: 17540661 · Received August 14, 2023

    Report

    Report Number
    MW5144517
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 9, 2023
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    HJN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHITE CIRCLE BURN MEASURING APPROXIMATELY 1CM X 1 CM ON THE PATIENT'S RIGHT FOREARM, NO INTERVENTION AT THIS TIME. TRANSILLUMINATOR FOUND TO BE WARM TO TOUCH. CONFIRMED A FAILURE WITHIN THAT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074531 TRANSILLUMINATOR TRANSILLUMINATOR, BATTERY-POWERED HJN STIHLER ELECTRONIC GMBH ASTODIA DIA120

    Patients

    Seq Age Sex Outcome Treatment
    1 1 WK Male Other