BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASC BAND

    MDR report key: 4100921 · Received September 19, 2014

    Report

    Report Number
    2134812-2014-00037
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    LEPU MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    DXC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONCLUSION OR ADMISSION BY VASCULAR SOLUTIONS, INC. THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE DEVICE FAILED OR MALFUNCTIONED IN ANY MANNER, OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH.

    Description of Event or Problem · 1

    AFTER PLACEMENT AND INFLATION OF A VASC BAND, STAFF NOTED PULSATILE BLOOD FLOW AND A BALLOONING OF THE PATIENT'S SKIN. THE PATIENT DEVELOPED A LARGE HEMATOMA, AND A HEMOBAND AND MANUAL COMPRESSION WERE USED TO STOP THE BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584142 VASC BAND VASCULAR CLAMP DXC LEPU MEDICAL TECHNOLOGY CO., LTD. 3524V 201311002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other