BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN PRODUCT INFORMATION

    MDR report key: 741575 · Received July 27, 2006

    Report

    Report Number
    1121308-2006-00009
    Event Type
    Other
    Date Received
    July 27, 2006
    Report Date
    July 14, 2006
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT RETURN IS NOT EXPECTED. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE PHYSICIAN (ALLERGIST) REPORTED THAT A PATIENT EXPERIENCED NAUSEA AND VOMITTING, FOLLOWING A CHIARI MALFORMATION PROCEDURE IN WHICH DURAGEN WAS APPLIED. WITHIN 24 HOURS OF THE PROCEDURE, THE PEDIATRIC PATIENT BEGAN THESE SYMPTOMS. EVIDENCE OF EOSINOPHILIA WAS FOUND IN THE CEREBRAL SPINAL FLUID (CSF). THE CHILD REMAINED HOSPITALIZED FOUR TO FIVE DAYS AND TREATED WITH DECADRON. THE SYMPTOMS SUBSIDED WITH TREATMENT. THE PATIENT HAS SINCE BEEN TAKEN OFF THE DECADRON AND THE SYMPTOMS HAVE RETURNED THREE (3) WEEKS AFTER THE PROCEDURE. IT IS UNKNOWN WHETHER OR NOT ANY OTHER PRODUCT WAS USED IN CONJUNCTION WITH THE DURAGEN, AND IF ANY OF THESE PRODUCTS WERE LEFT IN THE PATIENT. THE CHILD SHOWED A MILD SENSITIVITY TO BOVINE GELATIN LEADING TO THE PHYSICIAN'S CONCERN WITH DURAGEN. DURAGEN IS CONTRA-INDICATED FOR PATIENTS WITH A KNOWN HISTORY OF HYPERSENSITIVITY TO BOVINE DERIVED MATERIALS. BASED ON THE ACCOUNT'S PURCHASING HISTORY, THE INVOLVED PRODUCT WAS EITHER: ID2205 (LOT #1051134) OR ID3305 (LOT #1053369).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT INFORMATION DURAGEN GXQ INTEGRA LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization