BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOSEAL VHD

    MDR report key: 155141 · Received March 9, 1998

    Report

    Report Number
    9681824-1998-00206
    Event Type
    Injury
    Date Received
    March 9, 1998
    Date of Event
    July 31, 1997
    Report Date
    February 4, 1998
    Manufacturer
    COLLAGEN PRODUCTS DIV BIOPLEX CORP. A SUBSIDIARY OF DATASCOPE CORP.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON 7/25/1997 VASOSEAL WAS USED FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. SIX DAYS LATER THE PT PRESENTED WITH PAIN, REDNESS AND SOME DRAINAGE AT THE GROIN SITE. HE WAS READMITTED TO THE HOSP AND PLACED ON IV ANTIBIOTICS. CULTURE RESULTS SHOWED METHICILLIN RESISTANT STAPH AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOSEAL VHD VASCULAR HEMOSTASIS DEVICE MGB COLLAGEN PRODUCTS DIV BIOPLEX CORP. A SUBSIDIARY OF DATASCOPE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R