BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION

    MDR report key: 23829862 · Received December 17, 2025

    Report

    Report Number
    1824619-2025-00020
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 9, 2025
    Report Date
    December 31, 2025
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    HFX
    PMA / PMN Number
    K890897
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H3: DEVICE EVALUATED BY MANUFACTURER UPDATED H6: INVESTIGATION FINDINGS (C) UPDATED H6: INVESTIGATION CONCLUSIONS (D).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, ON (B)(6) 2025, THE CLAMP DID NOT TIGHTEN AS EXPECTED AND SEEMED LIKE IT WAS NOT ON THE CORRECT THREADS, "SO THE TWO EDGES OF SKIN WERE NOT ADEQUATELY CRUSHED TO ACHIEVE HEMOSTASIS." THE PROVIDER AND THE NURSE ATTEMPTED TO TIGHTEN THE CLAMP AND "IT WOULD NO LONGER TURN" AND THEY BELIEVED IT HAD REACHED FULL COMPRESSION. THE CLAMP WAS LEFT IN PLACE FOR A STANDARD OF 5 MINUTES, IT WAS VERY DIFFICULT TO REMOVE, AND THE "NEWBORN EXPERIENCED BLEEDING UPON REMOVAL. THE WOUND CONTINUED TO BLEED, REQUIRING THE PROVIDER TO SUTURE THE SKIN EDGES TOGETHER" ALONG "THE ENTIRE CIRCUMCISION SITE." PER THE FACILITY, "SURGICAL GAUZE WAS ALSO USED TO HELP CONTROL THE BLEEDING" AND THE "PROCEDURE REQUIRED SIGNIFICANTLY MORE TIME THAN USUAL TO COMPLETE. THE INFANT WAS FUSSY WAS AND REQUIRED EXTRA DOSES OF GLUCOSE TO REMAIN CALM DURING THE PROCEDURE." THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION AT THIS TIME. THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION. 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, ON (B)(6) 2025, THE CLAMP DID NOT TIGHTEN AS EXPECTED AND SEEMED LIKE IT WAS NOT ON THE CORRECT THREADS, "SO THE TWO EDGES OF SKIN WERE NOT ADEQUATELY CRUSHED TO ACHIEVE HEMOSTASIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617136 CENTURION CIRCLAMP W/1.1CM BELL AND INSERT HFX CENTURION MEDICAL PRODUCTS, LP 2025030501

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Other