BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 824844 · Received March 1, 2007

    Report

    Report Number
    MW1042136
    Event Type
    Injury
    Date Received
    March 1, 2007
    Date of Event
    December 23, 2006
    Report Date
    March 1, 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

    V PAD PLACED OVER LEFT GROIN PUNCTURE SITE. A 3-6 CM NECROTIC WOUND NOTED AFTER REMOVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization