BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION CIRCLAMP CIRCUMCISION

    MDR report key: 20049454 · Received August 22, 2024

    Report

    Report Number
    MW5158785
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 20, 2024
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    HFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN ATTEMPTING TO REMOVE THE GOMCO CLAMP, THE NUT BEGAN TO LOOSEN LIKE NORMAL, BUT THEN WAS SEEMINGLY STRIPPED AND UNABLE TO LOOSEN FURTHER. THE TOP PLATE WAS SLIGHTLY LOOSENED AND ALLOWED FOR PENIS TO BE REMOVED WITHOUT ISSUE/PULLING. AFTER PROCEDURE, GOMCO EVALUATED AND STILL COULD NOT UNSCREW NUT TO FULLY DISASSEMBLE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276206 CENTURION CIRCLAMP CIRCUMCISION CLAMP, CIRCUMCISION HFX CENTURION MEDICAL PRODUCTS, LP 2024041201

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Other| R