BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-GUARD BOVINE PERICARDIUM FOR DURA REPLACEMENT

    MDR report key: 36666 · Received September 9, 1996

    Report

    Report Number
    MW4001475
    Event Type
    Injury
    Date Received
    September 9, 1996
    Report Date
    September 5, 1995
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PARENTS OF A 10-YR-OLD MALE SPINA-BIFIDA PT ALLEGEDLY RECEIVED A UNIT OF CONTAMINATED (WITH FUNGUS) DURA SUBSTITUTE BOVINE PERICARDIUM. THE PARENTS REPORTED THE INCIDENT BECAUSE THEY HAD HEARD THAT ANOTHER CHILD WHO RECEIVED THE MATERIAL HAD DIED AND YET ANOTHER CHILD HAD THE MATERIAL EXPLANTED. WHEN A PRE-SURGICAL UNIT TESTED POSITIVE, THE EXPLANT WAS NEGATIVE. THE CHILD CONTINUES TO HAVE A LOW GRADE FEVER. THE CHILD HAD BRAINSTEM DECOMPRESSION SURGERY AND WAS ADMINISTERED STEROIDS POST-OP. STEROIDS SUPPRESS THE IMMUNE SYSTEM. ASPERGILLUS IS AN OPPORTUNISTIC ORGANISM IN IMMUNO-COMPROMISED PTS. THE CHILD HAS A CNS SHUNT IMPLANTED; 2 REVISIONS WERE NEEDED POST-OP. THE MFR SAID THEY HAD RECEIVED 2 REPORTS AND DID NOT THINK A PACKAGING PROBLEM COULD LEAD TO A FUNGAL CONTAMINATION DUE TO THE GEOMETRY. THE CO IS MFG THE SAME MATERIAL FOR PERICARDIAL AND VASCULAR REPAIR AND HAS BEEN ENGAGED IN MFG OF THIS MATERIAL SINCE THE 1980S. THEY HAVE IMPLANTED OVER 70,000 UNITS IN THAT TIME. THERE HAVE BEEN NO REPORTS OF SUCH CONTAMINATION, THOUGH THERE HAVE BEEN REPORTS OF LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-GUARD BOVINE PERICARDIUM FOR DURA REPLACEMENT Implant BOVINE PERICARDIUM FOR DURA REPLACEMENT GXQ BIO-VASCULAR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR