BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTODIA

    MDR report key: 23767913 · Received December 10, 2025

    Report

    Report Number
    MW5180225
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 2, 2025
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    HJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ASTODIA TRANSILLUMINATOR USED FOR PERIPHERAL INTRAVENOUS PLACEMENT - NURSE NOTED THAT BLISTERS WERE FORMING WHERE THE LIGHT TOUCHED INFANT'S ARM. INFANT HAD BLISTERING AND OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878243 ASTODIA TRANSILLUMINATOR, BATTERY-POWERED HJN STIHLER ELECTRONIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male