BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V PAD

    MDR report key: 826987 · Received March 8, 2007

    Report

    Report Number
    MW1042180
    Event Type
    Injury
    Date Received
    March 8, 2007
    Date of Event
    January 18, 2007
    Manufacturer
    INTER. V MED DEVICE TECHNOLOGIES; VEXXUS MEDICAL, INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SKIN BREAKDOWN AT CATHETER SITE. APPROX 1 X 1CM ULCERATED LESION OVER CATH SITE WITH YELLOWISH MUCOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V PAD * FRO INTER. V MED DEVICE TECHNOLOGIES; VEXXUS MEDICAL, INC. * VXT6M01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR CHLORA PREP