BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCLAMP W/1.3 CM BELL (ST)

    MDR report key: 22708508 · Received August 4, 2025

    Report

    Report Number
    1824619-2025-00012
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    May 31, 2025
    Report Date
    August 4, 2025
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, "AFTER CIRCUMCISION, BELL FELL OFF CHILD AS IF IT HAD CUT, INSTEAD OF COMPRESSED TISSUE. NO INITIAL BLEEDING. BLEEDING NOTED IN NURSERY WAS TREATED WTIH PRESSURE 10 MINUTES AND ADDITIONAL SURGICEL, THEN PRESSURE." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, 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, "AFTER CIRCUMCISION, BELL FELL OFF CHILD AS IF IT HAD CUT, INSTEAD OF COMPRESSED TISSUE. NO INITIAL BLEEDING. BLEEDING NOTED IN NURSERY WAS TREATED WTIH PRESSURE 10 MINUTES AND ADDITIONAL SURGICEL, THEN PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277436 CIRCLAMP W/1.3 CM BELL (ST) HFX CENTURION MEDICAL PRODUCTS, LP 2025051201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other