BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 16432033 · Received February 23, 2023

    Report

    Report Number
    3006232063-2023-00004
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 23, 2023
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD SHOWED THAT THIS DEVICE WAS STERILIZED WITHIN NORMAL PARAMETERS AND NO NONCONFORMANCES OR DEVIATIONS WERE NOTED FOR THE STERILIZATION PROCESS.

    Description of Event or Problem · 0

    PATIENT HAD A SUCCESSFUL BARRICAID IMPLANT ON (B)(6) 2022, AND DEVELOPED A LUMBAR EPIDURAL ABSCESS AND REQUIRED SURGERY TO TREAT THE INFECTED AREA ON (B)(6) 2023. PATIENT WAS TREATED FOR THE INFECTION AND THE BARRICAID DEVICE WAS LEFT IMPLANTED IN THE PATIENT AT TIME OF CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678529 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 07212001 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Other