BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 20056250 · Received August 23, 2024

    Report

    Report Number
    3006232063-2024-00031
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    June 7, 2024
    Report Date
    August 23, 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

    INTERVIEW WITH SURGEON STATED THEY DIDN'T SUSPECT THAT THE DEVICE WAS RESPONSIBLE, INTRINSIC IS REPORTING AS POTENTIALLY RELATED. 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

    DURING DISCUSSION WITH SURGEON, HE MENTIONED THAT APPROXIMATELY 1 WEEK AFTER SURGERY, THE PATIENT WENT TO THE EMERGENCY ROOM WITH A FEVER AND HAD THE WOUND DRAINED. THE PATIENT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482219 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-10MM 08242308 M906BARA810MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other