BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRC BELL AND INSERT

    MDR report key: 1938524 · Received December 22, 2010

    Report

    Report Number
    MW5018685
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CENTURION MEDICAL PRODUCTS CORP.
    Product Code
    FHG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON APPLIED GOMCO AND BELL TO INFANT AND TURNED THE CLAMP UNTIL TIGHT. SURGEON CONCERNED THAT SOMETHING DID NOT FEEL RIGHT SO RATHER THAN MAKE USUAL INCISION WITH THE BLADE, MADE A SMALL "NICK". THERE WAS MUCH BLOOD INDICATING THAT THE CLAMP HAD NOT CAUSED HEMOSTASIS AT WHICH TIME SURGEON REMOVED THE GOMCO AND BELL, HELD PRESSURE UNTIL RN COULD GET ANOTHER 1.1 BELL WITH A MATCHING 1.1 RING. NEW RING PLACED ON GOMCO AND BELL APPLIED TO INFANT AND PROCEDURE COMPLETED WITHOUT INCIDENCE. APPROX 5 ML OF BLOOD LOSS DUE TO BELL (1.1) NOT MATCHED WITH CORRECT RING (PACKAGE FROM CENTURION HAD A 1.3 RING IN THE 1.1 PACKAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRC BELL AND INSERT FHG CENTURION MEDICAL PRODUCTS CORP. 2010080901

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Life Threatening| R