BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD

    MDR report key: 122231 · Received September 22, 1997

    Report

    Report Number
    2183620-1997-00017
    Event Type
    Injury
    Date Received
    September 22, 1997
    Date of Event
    September 4, 1996
    Report Date
    September 22, 1997
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    GXQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A DURA-GUARD IMPLANT CARD WAS RETURNED TO BIO-VASCULAR, INC. INDICATING THAT THIS PRODUCT WAS USED FOR AN OPHTHALMIC PROCEDURE. BVI FOLLOWED UP WITH THE CLINIC TO OBTAIN MORE INFO. THE DR EXPLAINED THAT THIS PRODUCT WAS USED FOR A GLAUCOMA WRAP PROCEDURE ON THE LEFT EYE. THE DEVICE WAS IMPLANTED ON 03/20/96. THE PT EXPERIENCED CONJUNCTIVAL INFLAMMATION AND THE DURA-GUARD WAS EXPLANTED ON 09/04/96. PT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-GUARD Implant DURAL REPAIR PATCH GXQ BIO-VASCULAR, INC. DG-0404S DGS-95H17-147

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention