BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASC BAND

    MDR report key: 3802267 · Received May 9, 2014

    Report

    Report Number
    2134812-2014-00018
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    LEPU MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    DXC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED A MODERATELY SIZED HEMATOMA AFTER AN INFLATED VASC BAND LOST PRESSURE. PRESSURE WAS APPLIED AND NO FURTHER NEGATIVE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280658 VASC BAND RADIAL HEMOSTAT DXC LEPU MEDICAL TECHNOLOGY CO., LTD. 3524V 201310004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other