BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCLAMP WITH 1.3 CM BELL

    MDR report key: 2821135 · Received October 31, 2012

    Report

    Report Number
    MW5027463
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 26, 2012
    Manufacturer
    CENTURION MEDICAL PRODUCTS CORP
    Product Code
    HFX
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CIRCUMCISION WAS PERFORMED. AFTER REMOVING FORESKIN BELL SLIPPED OUT OF THE GLANS BUT THE BELL WAS STILL ATTACHED TO CLAMP. BABY HAD SOME BLEEDING ON VENTRAL SIDE-PRESSURE APPLIED AND USE OF GEL FOAM AND SURGICEL TO STOP BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCLAMP WITH 1.3 CM BELL CIRCLAMP HFX CENTURION MEDICAL PRODUCTS CORP 2012060401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention