BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 10861539 · Received November 18, 2020

    Report

    Report Number
    3006232063-2020-00008
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 18, 2020
    Manufacturer
    INTRINSIC THERAPEUTICS, INC.
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED.

    Description of Event or Problem · 1

    THERE WAS A DURAL TEAR CAUSED BY USE OF BARRICAID LOADED APPLICATOR. AFTER CREATED THE DEFECT MEASUREMENT, ALIGNMENT TRIAL WAS BROUGHT IN SITU AND WITH A FEW ADJUSTMENT, IT WAS POSITIONED PROPERLY. THE LOADED APPLICATOR WAS INSERTED AFTER THAT. THE PHYSICIAN USED SUCTION TO RETRACT THE NEURAL STRUCTURES (DEFECT POSITIONED LATERALLY) AND INSERTED THE APPLICATOR TOO CAUDALLY (MISSED THE DEFECT). DURING ADJUSTMENT ATTEMPT, DURAL TEAR WAS DISCOVERED. TEAR HAS BEEN REPAIRED WITH SUTURES AND GLUE AND THE WOUND HAS BEEN CLOSED WITHOUT FURTHER IMPLEMENTATION ATTEMPTS. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323405 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC. BAR-A8-8MM 06152001-22

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention