BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD

    MDR report key: 208245 · Received January 29, 1999

    Report

    Report Number
    2183620-1999-00008
    Event Type
    Injury
    Date Received
    January 29, 1999
    Date of Event
    December 23, 1998
    Report Date
    January 29, 1999
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    DXZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON INFORMED BIO-VASCULAR, INC. THAT ON 11/10/1998, A CAROTID PATCH ENDARTERECTOMY WAS PERFORMED ON THE PT TO TREAT CAROTID STENOSIS. THE SURGEON USED VASCU-GUARD AS THE CLOSURE PATCH MATERIAL. ON 12/23/1998, THE PT PRESENTED WITH AN ABSCESS ON HIS NECK INVOLVING THE PATCH. THE SAME DAY, THE SURGEON PERFORMED OPEN DRAINAGE AND DEBRIDEMENT OF THE WOUND SITE. THE VASCU-GUARD PATCH WAS NOT LEAKING AND WAS NOT REMOVED. NO HARM HAS COME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCU-GUARD Implant VASCULAR TISSUE PATCH DXZ BIO-VASCULAR, INC. VG-0106 VGS-98E05-148

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R