BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 19932752 · Received August 7, 2024

    Report

    Report Number
    3006232063-2024-00030
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 7, 2024
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA810MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PHYSICIAN FIRST CONTACTED INTRINSIC REPRESENTATIVE ON JULY 09TH TO STATE THERE WAS AN INFLAMMATORY RESPONSE TO THE IMPLANT. ON (B)(6) 2024 THE SITE WAS ASPIRATED AND CULTURED AND NO CSF LEAK OR BACTERIAL CULTURES WERE OBSERVED. A FOLLOW-UP SURGERY WAS PERFORMED ON (B)(6) 2024 WHERE THE BARRICAID IMPLANT WAS REMOVED AND THERE WAS A CONFIRMED SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518266 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-10MM 08242308 M906BARA810MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other