BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOSCOPE TRANSILLUMINATOR

    MDR report key: 10100883 · Received May 28, 2020

    Report

    Report Number
    MW5094744
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 27, 2020
    Manufacturer
    VENOSCOPE, LLC
    Product Code
    HJN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON USING THE VENOSCOPE TRANSILLUMINATOR DEVICE ON NEWBORN INFANT A SKIN INJURY WITH BLISTERING OCCURRED IN TWO LOCATIONS ON INFANT ARM WHERE DEVICE WAS USED TO GAIN VESSEL ACCESS. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559075 VENOSCOPE TRANSILLUMINATOR TRANSILLUMINATOR, BATTERY-POWERED HJN VENOSCOPE, LLC VENOSCOPE II

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention