BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 21322191 · Received February 6, 2025

    Report

    Report Number
    3006232063-2025-00003
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 19, 2026
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DESCRIPTION OF THE ISSUE AND THE IMAGES SHARED, THE PATIENT APPEARS TO HAVE REHERNIATED AND THE BARRIER (SEAL) PORTION OF THE DEVICE MIGRATED WITH THE HERNIATED MATERIAL. THE DESCRIPTION OF THE EVENTS DETAILED IN THIS MDR REPRESENT INTRINSIC THERAPEUTIC'S UNDERSTANDING AT THE TIME OF SUBMISSION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS.

    Additional Manufacturer Narrative · 0

    BASED ON THE DESCRIPTION OF THE ISSUE AND THE IMAGES SHARED, THE PATIENT APPEARS TO HAVE REHERNIATED AND THE BARRIER (SEAL) PORTION OF THE DEVICE MIGRATED WITH THE HERNIATED MATERIAL. THE DESCRIPTION OF THE EVENTS DETAILED IN THIS MDR REPRESENT INTRINSIC THERAPEUTIC'S UNDERSTANDING AT THE TIME OF SUBMISSION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS. FOLLOW UP #1: CORRECTION TO THE DETAILS PREVIOUSLY PROVIDED, THE MESH (SEAL) PORTION OF THE DEVICE DID NOT MIGRATE BUT WAS "BUNCHED" AND THE HERNIATED MATERIAL WENT AROUND THE MESH. INVESTIGATION FINDINGS CODE CHANGED FROM "MIGRATION" TO "USAGE PROBLEM IDENTIFIED" DUE TO BUNCHED MESH DURING DELIVERY.

    Description of Event or Problem · 0

    IMPLANTATION OCCURRED ON (B)(6) 2024 AND ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING SOME DISCOMFORT. THE SURGEON REPORTED THE DEVICE MIGHT HAVE "MIGRATED MEDIALLY" INITIALLY. ORIGINAL IMPLANTATION IMAGES WERE REVIEWED, AND IT APPEARS THE BARRIER WAS BUNCHED BASED ON THE LOCATION OF THE MARKER. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2025 AND THE DEVICE WAS REMOVED. IMAGES SHARED AFTER THE REVISION SURGERY SHOWED THERE HAD BEEN A REHERNIATION AND THE BARRIER HAD MIGRATED OUT OF THE DISC SPACE.

    Description of Event or Problem · 0

    IMPLANTATION OCCURRED ON (B)(6) 2024, AND ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING SOME DISCOMFORT. THE SURGEON REPORTED THE DEVICE MIGHT HAVE "MIGRATED MEDIALLY" INITIALLY. ORIGINAL IMPLANTATION IMAGES WERE REVIEWED, AND IT APPEARS THE BARRIER WAS BUNCHED BASED ON THE LOCATION OF THE MARKER. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2025 AND THE DEVICE WAS REMOVED. IMAGES SHARED AFTER THE REVISION SURGERY SHOWED THERE HAD BEEN A REHERNIATION AND THE BARRIER HAD MIGRATED OUT OF THE DISC SPACE. FOLLOW UP #1: THE FULL INVESTIGATION CONTACTED THE IMPLANTING AND REMOVAL SURGEON AND CONCLUDED THAT THE IMPLANT DID NOT MOVE FROM THE ORIGINAL POSITION, BUT THE HERNIA WENT AROUND THE DEVICE WHICH WAS "BUNCHED". THIS WAS NOT APPARENT WHEN REVIEWING JUST THE IMAGES ON THE INITIAL MDR SUBMISSION. THE EXTRA DETAILS FROM THE SURGEON INTERVIEW CLARIFIED THE STATUS OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531846 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 05072402 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other