BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ACTIVE CORD

    MDR report key: 615523 · Received June 3, 2005

    Report

    Report Number
    1037905-2005-00062
    Event Type
    Malfunction
    Date Received
    June 3, 2005
    Date of Event
    April 1, 2005
    Report Date
    May 5, 2005
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE WILSON-COOK UNIVERSAL ACTIVE CORD, THE USER NOTED THAT THE CONNECTION WAS LOOSE. THE ELECTRICAL INSERT IN THE ACTIVE CORD HAD RECESSED, PROHIBITING PROPER CONNECTION WITH THE ACCESSORY DEVICE. ANOTHER ACTIVE CORD WAS USED TO COMPLETE THE PROCEDURE. AN INJURY TO THE PT DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL ACTIVE CORD MISCELLANEOUS FFZ WILSON-COOK MEDICAL, INC. NA W2046327

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN