BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCLAMP W/1.1CM BELL (ST)

    MDR report key: 22639457 · Received July 28, 2025

    Report

    Report Number
    1824619-2025-00011
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 28, 2025
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED EXCESSIVE BLEEDING DURING CIRCUMCISIONS FROM THE CLAMPS "NOT TIGHTENING DOWN COMPLETELY" AND FEELING A "CRUNCHY" SENSATION. THE CUSTOMER REPORTED THAT WHEN "RELEASING THE NUT, IT DOESN'T FEEL LIKE THERE IS ANY PRESSURE AS WELL AS WHEN TIGHTENING." THE CUSTOMER ALSO REPORTED "BLEEDING AROUND THE RIM OF THE HEAD OF THE PENIS AS OPPOSED TO THE UNDERSIDE" AND THAT THE PHYSICIANS ARE "LEAVING THE CLAMPS ON FOR A FULL FIVE MINUTES." THE CUSTOMER REPORTED THERE WAS NO SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE REQUIRED RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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

    THE CUSTOMER REPORTED EXCESSIVE BLEEDING DURING CIRCUMCISIONS FROM THE CLAMPS "NOT TIGHTENING DOWN COMPLETELY" AND FEELING A "CRUNCHY" SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412175 CIRCLAMP W/1.1CM BELL (ST) HFX CENTURION MEDICAL PRODUCTS, LP 2025031901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other