BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD

    MDR report key: 472703 · Received July 18, 2003

    Report

    Report Number
    2183620-2003-00014
    Event Type
    Injury
    Date Received
    July 18, 2003
    Date of Event
    June 1, 2003
    Report Date
    June 23, 2003
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    GXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 06/2003 MANUFACTURER WAS NOTIFIED OF A PT WHO EXHIBITED WHAT APPEARED TO BE AN ACUTE INFLAMMATORY RESPONSE FOLLOWING IMPLANTATION OF DURA-GUARD (EXACT DATE UNK). THE DEVICE WAS THEN EXPLANTED (2003, EXACT DATE UNK) RESULTING IN A REDUCTION OF THE PT'S SYMPTOMS. PT STATUS WAS THEN ASSESSED AS "BETTER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-GUARD DURAL REPAIR PATCH GXO SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R