BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCLAMP W/1.1CM BELL (ST)

    MDR report key: 22743444 · Received August 7, 2025

    Report

    Report Number
    1824619-2025-00016
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    July 9, 2025
    Report Date
    September 15, 2025
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H6: INVESTIGATION FINDINGS. UPDATE TO H6: INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, AFTER USING THE CLAMP THERE WAS "BLEEDING AFTER CIRCUMCISION" THAT REQUIRED PRESSURE AND "ADDITIONAL SURGICEL" WHICH "FAILED AND REQUIRED NICU RAPID RESPONSE". NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE. 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

    ACCORDING TO THE CUSTOMER, AFTER USING THE CLAMP THERE WAS "BLEEDING AFTER CIRCUMCISION" THAT REQUIRED PRESSURE AND "ADDITIONAL SURGICEL" WHICH "FAILED AND REQUIRED NICU RAPID RESPONSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866463 CIRCLAMP W/1.1CM BELL (ST) HFX CENTURION MEDICAL PRODUCTS, LP 2025040901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other