BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTODIA (CONTROL UNIT)

    MDR report key: 18605494 · Received January 30, 2024

    Report

    Report Number
    18605494
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 19, 2024
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    HJN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT BORN PREMATURELY AT 37 WEEKS GESTATION. INFANT REQUIRED CARE IN SPECIAL CARE NURSERY. ON DOL (DAY OF LIFE) #1, INFANT DEVELOPED 2 BLISTERS (1 ON LEFT ARM & 1 ON LEFT HAND). THE BLISTERS WERE ASSESSED BY PROVIDER & WOUND CARE AND CARED FOR WITH DRESSING CHANGES. IT WAS LATER DETERMINED THESE 2 BLISTERS WERE A BURN RELATED TO A TRANSILLUMINATOR USED TO ASSIST WITH BLOOD COLLECTION. THE INFANT HAS REQUIRED ON-GOING DRESSING CHANGES TO THE AREA AND IS BEING FOLLOWED BY PLASTIC SURGERY FOR WOUND MANAGEMENT. NO ACUTE INTERVENTIONS HAVE BEEN NEEDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545780 ASTODIA (CONTROL UNIT) TRANSILLUMINATOR, BATTERY-POWERED HJN STIHLER ELECTRONIC GMBH DIA120

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown Other