BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD

    MDR report key: 139441 · Received December 19, 1997

    Report

    Report Number
    2183620-1997-00024
    Event Type
    Injury
    Date Received
    December 19, 1997
    Report Date
    December 18, 1997
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    GXQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT PROVIDING ADDITIONAL INFO REGARDING THIS INCIDENT. THE SURGEON PROVIDED ADDITIONAL INFO AS FOLLOWS: IT WAS FOUND THAT A CULTURE WAS TAKEN FROM THE IMPLANT AND THERE WAS NO CONTAMINATION FROM THE DURA-GUARD IMPLANT ITSELF. FURTHERMORE, THERE IS NO INFLAMMATION AROUND THE DURAL GRAFT. THE SURGEON STATED THAT THE DURA-GUARD TISSUE IMPLANT IS NOT RESPONSIBLE FOR THE PT'S LOW-GRADE FEVERS AND CHRONIC MALAISE. AT THIS POINT, THE PT CONTINUES TO DO WELL. THE SURGEON IS PLEASED WITH HER PROGRESS AND STATED THAT HE DID NOT BELIEVE THAT AN MDR REPORT NEEDED TO BE SUBMITTED. NOTE THAT THIS INFO WAS NOT FORWARDED TO BIO-VASCULAR, INC. UNTIL AFTER THE 30 DAY TIME LIMIT FOR SUBMITTING AN INITIAL MDR REPORT.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT HE HAD CONCERN ABOUT A CRANIAL SURGICAL PROCEDURE HE PERFORMED IN THE POSTERIOR FOSSA REGION. THE PT HAD A TITANIUM PLATE PUT IN. DURA-GUARD WAS USED AS A DURAL CLOSURE PATCH. THE PT RAN A FEVER TWO MONTHS AFTER THE PROCEDURE WAS PERFORMED AND THE DURA-GUARD WAS EXPLANTED. BIO-VASCULAR INC HAS ATTEMPTED TO OBTAIN MORE INFO REGARDING THIS INCIDENT FROM THE SURGEON WITH NO SUCCESS, HOWEVER, CO WILL CONTINUE TO PURSUE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-GUARD Implant DURAL REPAIR PATCH GXQ BIO-VASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R