BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTODIA (CONTROL UNIT)

    MDR report key: 18605458 · Received January 30, 2024

    Report

    Report Number
    18605458
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    December 29, 2023
    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 36 WKS & 2 DAYS GESTATION, REQUIRING CARE IN SPECIAL CARE NURSERY. ON DOL (DAY OF LIFE) #1, INFANT WAS NOTED TO HAVE A BLISTER ON THE LEFT ELBOW. ETIOLOGY OF BLISTER WAS UNKNOWN AT THAT TIME, BUT MULTIPLE POTENTIAL CAUSES WERE CONSIDERED. WOUND CARE WAS CONSULTED & ASSISTED W/ WOUND MANAGEMENT. IT WAS LATER DETERMINED THE WOUND WAS A BURN, THOUGHT TO BE CAUSED BY A VEIN TRANSILLUMINATOR (ANOTHER EVENT NOTED RELATED TO THIS DEVICE HAS BEEN REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550556 ASTODIA (CONTROL UNIT) TRANSILLUMINATOR, BATTERY-POWERED HJN STIHLER ELECTRONIC GMBH DIA120

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown Other