BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 23681619 · Received December 1, 2025

    Report

    Report Number
    3006232063-2025-00047
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 1, 2025
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF PRODUCTION RECORDS SHOWS THE DEVICE WAS STERILIZED WITH NO ANOMALIES DETECTED. 3 OTHER LOTS THAT WERE STERILIZED AT THE SAME TIME HAVE NOT HAD ANY INFECTIONS REPORTED. 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 NEW INFORMATION SUBMITTED, ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS.

    Description of Event or Problem · 0

    THE PATIENT EXPERIENCED AN INFECTION. THE SURGEON REMOVED THE DEVICE DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150404 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 05072402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O