BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL CURITY

    MDR report key: 424752 · Received October 24, 2002

    Report

    Report Number
    MW1026545
    Event Type
    Malfunction
    Date Received
    October 24, 2002
    Date of Event
    September 26, 2002
    Report Date
    October 1, 2002
    Manufacturer
    KENDALL CO, DIV OF TYCO INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACKAGES NOT SEALED PROPERLY ON SCALPEL, THEREFORE ASSUMED NOT STERILE. ONLY 9 IN BOX, CAREGIVERS FEEL ONE HAD BEEN REMOVED AND USED ON ONE OF THE TWO IDENTIFIED PTS. THE REMAINING 9 WERE REMOVED FROM SVC. STAFF CANNOT DETERMINE WHICH PT THIS ONE WAS USED ON. NEITHER HAS ANY DOCUMENTED INFECTION AT THE DATE OF THIS REPORT. BOX WITH UNSEALED SCALPELS WERE REMOVED FROM SVC. NOTE: 7 FR. SHEATH (ST. JUDE) LIVE WIRE (BIOSCIENCE WEBSTER) SELDINGER NEEDLE (COOK) SYRINGES (CURITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL CURITY #11 BLADE SCALPEL GES KENDALL CO, DIV OF TYCO INC. * 205600

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other