BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 14435066 · Received May 19, 2022

    Report

    Report Number
    1121308-2022-00033
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    February 11, 2022
    Report Date
    July 18, 2022
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE, AS SUCH ONLY A DHR REVIEW COULD BE PERFORMED: DEVICE HISTORY RECORD (DHR) REVIEW - AT THE TIME OF MANUFACTURING RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. FAILURE ANALYSIS & ROOT CAUSE - THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. A DHR REVIEW AND TRENDING WERE PERFORMED AS PART OF THE EVALUATION. PROPER FINISHED GOOD TESTING WAS PERFORMED PRIOR TO RELEASE AS INDICATED IN THE DHR. PRODUCT WAS NOT RECEIVED FOR ANALYSIS AND THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT. MEDICAL ASSESSMENT - A MEDICAL ASSESSMENT WAS PERFORMED BY INTEGRA MEDICAL AFFAIRS AND CONCLUDED THAT THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THAT THE PRODUCT WAS CAUSAL TO THE REPORTED EVENTS, AS IT APPEARS TO BE PROCEDURALLY RELATED. AS PER PRODUCT INSERT, INFECTION IS AN OBSERVED ADVERSE EVENT. HOWEVER, PER COMPLAINT, THE SURGEON HAD REPORTS OF INFECTION ON THREE DIFFERENT PATIENTS POST-OPERATIVELY, EACH ONE WITH A DIFFERENT ORGANISM. ALL PATIENTS WERE TREATED WITH MEDICAL AND/OR SURGICAL INTERVENTION. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS FOR "PATIENT A" REPRESENTING 1 OF 3 REPORTS, AND LINKED TO MFG REPORT NUMBERS: 1121308-2022-00034; 1121308-2022-00035. A FACILITY REPORTED THAT DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS USED IN A CRANIOTOMY PROCEDURE, AND 3 CONSECUTIVE INFECTIONS OCCURRED. "PATIENT A" DEVELOPED MENINGITIS 10 DAYS POSTOPERATIVELY; CEREBROSPINAL FLUID (CSF) CULTURE AND GRAM STAIN WAS OBTAINED ON 2/21/2022, AND GROWTH FROM THE CSF CULTURE WAS POSITIVE ON 2/23/2022 FOR P. MIRABILIS. INFECTIOUS DISEASE CONSULT WAS OBTAINED AND PATIENT TREATED WITH VANCOMYCIN AND MEROPENEM. PATIENT A REMAINED HOSPITALIZED UP TO 4/25/2022 WHEN INTEGRA BECAME AWARE. NO SURGICAL DELAY HAS BEEN REPORTED. THE FACILITY IS INVESTIGATING TO DETERMINE THE SOURCE OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260572 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON 60345799

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female