BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCLAMP W/1.1CM BELL (ST)

    MDR report key: 22635878 · Received July 28, 2025

    Report

    Report Number
    1824619-2025-00010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED EXCESSIVE BLEEDING DURING CIRCUMCISION FROM THE CLAMP "NOT TIGHTENING DOWN COMPLETELY." 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 IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED EXCESSIVE BLEEDING DURING CIRCUMCISION FROM THE CLAMP "NOT TIGHTENING DOWN COMPLETELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686352 CIRCLAMP W/1.1CM BELL (ST) HFX CENTURION MEDICAL PRODUCTS, LP 2024121801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other