BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 1403435 · Received June 15, 2009

    Report

    Report Number
    1451040-2009-00001
    Event Type
    Malfunction
    Date Received
    June 15, 2009
    Date of Event
    March 13, 2003
    Report Date
    June 15, 2009
    Manufacturer
    CHANGZHOU CONCORDS PLASTIC PRODUCTS CO., LTD.
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS COMMUNICATED TO US BY THE USER FACILITY: THE BLADE ON THE CORD CLAMP REMOVER DISLODGED WHILE REMOVING CLAMP, WHICH BECAME STUCK ON THE CLAMP WHILE ATTACHED TO THE BABY. THE BLADE WAS LOOSE, BUT DEVICE COULD NOT BE EASILY REMOVED FROM THE BABY. IT TOOK THE EFFORT OF THREE RN'S TO REMOVE THE BLADE AND CLAMP. THE BABY WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE CORD CLAMP REMOVER, UMBILICAL HFW CHANGZHOU CONCORDS PLASTIC PRODUCTS CO., LTD. CCG09-31

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Other