BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 14434804 · Received May 19, 2022

    Report

    Report Number
    1121308-2022-00035
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    March 29, 2022
    Report Date
    July 13, 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. DEVICE HISTORY RECORD (DHR) REVIEW - LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. FAILURE ANALYSIS & ROOT CAUSE - WITH THE INFORMATION PROVIDED A ROOT CAUSE COULD NOT BE DETERMINED, AS THERE IS NO WAY TO RELIABLY DETERMINE WHY THE REPORTED CONDITION OCCURRED. MOST LIKELY ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER "INFECTION" HAS AN ACCEPTABLE RISK OF PACKAGING INTEGRITY AND STERILIZATION WITH AN IMPROBABLE OCCURRENCE. 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. 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 C" REPRESENTING 3 OF 3 REPORTS, AND LINKED TO MFG REPORT NUMBERS: 1121308-2022-00033 AND 1121308-2022-00034. 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 C" DEVELOPED A DEEP INCISIONAL PRIMARY (DIP) SURGICAL SITE INFECTION 24 DAYS POSTOPERATIVELY. PATIENT C WAS RETURNED TO SURGERY ON (B)(6) 2022 FOR WASHOUT OF LUMBAR WOUND AND DEBRIDEMENT OF DEVITALIZED TISSUE. SURGICAL FINDINGS PER MD'S PROGRESS NOTE STATES "VERY LARGE FOREIGN BODY REACTION WITH FIRM MASS UNDERNEATH FASCIAL LAYER. WOUND DEHISCENCE AND ACTIVE PUS" OF THE WOUND; WOUND CULTURE WAS POSITIVE FOR S. AUREUS FROM THE DEEP INCISIONAL SITE. INFECTIOUS DISEASE CONSULT WAS OBTAINED AND PATIENT TREATED WITH VANCOMYCIN AND ZOSYN. PATIENT C HAS BEEN DISCHARGED HOME WITH IV ANTIBIOTICS. 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
    293734 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 Male