BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 22797782 · Received August 13, 2025

    Report

    Report Number
    3006232063-2025-00035
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Report Date
    August 13, 2025
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IMPLANTED WAS NOT REPORTED, BUT DUE TO THE LOCATION (GERMANY) IT WOULD LIKELY HAVE BEEN A BAR-D8-10X14 OR BAR-D8-8X14 WHICH IS NOT MARKETED IN THE US. THIS DEVICE WOULD HAVE BEEN SOLD IN THE EU PRIOR TO US COMMERCIALIZATION. THIS DEVICE IS SIMILAR TO THE BAR-A8-8MM OR BAR-A8-10MM DEVICE THAT IS MARKETED IN THE US UNDER THE PMA NUMBER DOCUMENTED ON THIS 3500A. 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.

    Description of Event or Problem · 0

    A REPORT OF A REMOVAL SURGERY WAS SCHEDULED FOR A PATIENT IMPLANTED DUE TO "...MESH FLIP OVER AND RECURRENCE OF SYMPTOMS" FROM A PHYSICIAN IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79314 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R