BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOSEAL VHD

    MDR report key: 220927 · Received April 26, 1999

    Report

    Report Number
    9681824-1999-00038
    Event Type
    Injury
    Date Received
    April 26, 1999
    Date of Event
    March 22, 1999
    Report Date
    March 25, 1999
    Manufacturer
    DATASCOPE CORP./COLLAGEN PRODUCTS
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE TECHNOLOGIST REPORTED THAT ON 3/22/1999, THE PT DEVELOPED A LARGE HEMATOMA AND A SMALL PSEUDOANEURYSM POST VASOSEAL DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOSEAL VHD VASCULAR HEMOSTASIS DEV. MGB DATASCOPE CORP./COLLAGEN PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR HEPARIN.