BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPAD

    MDR report key: 822616 · Received February 23, 2007

    Report

    Report Number
    MW1042055
    Event Type
    Injury
    Date Received
    February 23, 2007
    Date of Event
    February 6, 2007
    Report Date
    February 23, 2007
    Manufacturer
    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

    VPAD USED OVER NIGHT GROIN PUNCTURE SITE. FOLLOWING REMOVAL, 4CM LONG X 1.5 CM WIDE THIN, GREY NECROTIC WOUND NOTICED. USED LESS THAN 24 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAD * FRO VEXXUS MEDICAL INC * VXT6H01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization CHLORAPREP