BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPAD

    MDR report key: 3542044 · Received December 18, 2013

    Report

    Report Number
    3542044
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    December 4, 2013
    Report Date
    December 17, 2013
    Manufacturer
    VEXXUX MEDICAL INC. ANGIOTECH MEDICAL TECNOLOGIES
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS A (B)(6) PATIENT UNDERWENT A CARDIAC CATH VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2013. POST PROCEDURE THE RIGHT FEMORAL SHEATH WAS DISCONTINUED AND A VPAD WAS APPLIED FOR 25 MINUTES CONSISTENT WITH THE RECOMMENDED TIME UNTIL HEMOSTASIS WAS ACHIEVED. DURING SITE INSPECTION A BLACK AND BLUE DISCOLORATION OF THE SKIN WAS NOTED. THE PHYSICIAN ASSESSMENT REVEALED POSSIBLE CHEMICAL BURN. THE AFFECTED AREA WAS CLEANED WITH NORMAL SALINE AND A SILVIDENE CREAM WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660841 VPAD VPAD GEI VEXXUX MEDICAL INC. ANGIOTECH MEDICAL TECNOLOGIES NA VXT13G01

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention