BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD

    MDR report key: 5087070 · Received September 18, 2015

    Report

    Report Number
    1416980-2015-36448
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 4, 2015
    Report Date
    October 22, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    GXQ
    PMA / PMN Number
    K982282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). CORRECTED INFORMATION: (TO INCLUDE INFORMATION OMITTED ON INITIAL). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A HEADACHE AND AN INFECTION AFTER UNDERGOING A PROCEDURE IN WHICH A DURA-GUARD PATCH WAS USED FOR DURAL REPAIR. THE CAUSE OF THE HEADACHE AND THE INFECTION WAS NOT REPORTED. THE INDICATION FOR THE DURAL REPAIR WAS NOT REPORTED. NO FURTHER DETAIL ON THE SURGICAL TECHNIQUE WAS PROVIDED. ON AN UNREPORTED DATE 17-18 DAYS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A HEADACHE AND AN UNSPECIFIED INFECTION (NO FURTHER DETAIL WAS PROVIDED). TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE HEADACHE AND INFECTION WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619009 DURA-GUARD DURA SUBSTITUTE GXQ SYNOVIS SURGICAL INNOVATIONS SP15D21-1045953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other