BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOSCOPE II

    MDR report key: 6072216 · Received November 2, 2016

    Report

    Report Number
    6072216
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 31, 2016
    Manufacturer
    VENOSCOPE
    Product Code
    HJM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSILLUMINATOR WAS USED TO IDENTIFY SUITABLE VEIN IN LEFT UPPER ARM FOR IV PLACEMENT FOR TPN INFUSION-DEVICE ON SKIN OFF/ON FOR 2 MINUTE PERIOD. AREA OF SKIN WAS NOTED TO BE WARM TO THE TOUCH AND HARD WHEN THE TRANSILLUMINATOR WAS REMOVED FROM THE ARM - LEFT ARM BLISTER AREA OF INJURY: 1.5 CM X 7 CM. MEPILEX DRESSING TO SITE; REMOVED ON (B)(6) 2016 AND LEFT OPEN TO AIR. SITE SCABBED OVER AS OF (B)(6) 2016. WE HAVE 2 DEVICES. DO NOT KNOW WHICH DEVICE WAS USED. DEVICE A AND DEVICE B. AGE OF DEVICE: DEVICE 1 - 6 YEARS; DEVICE 2 - 8 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723913 VENOSCOPE II TRANSILLUMINATOR HJM VENOSCOPE VENOSCOPE II
    723914 VENOSCOPE II TRANSILLUMINATOR HJM VENOSCOPE VENOSCOPE II

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Other