BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCLAMP W/1.1CM BELL (ST)

    MDR report key: 19872920 · Received July 31, 2024

    Report

    Report Number
    1824619-2024-00008
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 31, 2024
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, "THERE WAS CIRCUMFERENTIAL BLEEDING THAT OCCURRED, EVEN THOUGH THE CLAMPS WERE TIGHTENED APPROPRIATELY AND LEFT ON > 6 MINUTES, WHICH IS THE GUIDELINE. THIS OCCURS AT THE END OF THE PROCEDURE, WHEN THE CLAMP WAS REMOVED. THE MOST RECENT EVENT WAS ON 7/2/2024. ALL OF THE PATIENTS REQUIRED WITHER CAUTERY, SURGICAL, OR STITCHES IN ORDER TO STOP THE BLEEDING; ALL PATIENTS ARE CURRENTLY DOING WELL" A SAMPLE IS AVAILABLE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, "THERE WAS CIRCUMFERENTIAL BLEEDING THAT OCCURRED, EVEN THOUGH THE CLAMPS WERE TIGHTENED APPROPRIATELY AND LEFT ON > 6 MINUTES, WHICH IS THE GUIDELINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239902 CIRCLAMP W/1.1CM BELL (ST) HFX CENTURION MEDICAL PRODUCTS, LP 2024042201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other