BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL KENGUARD

    MDR report key: 283831 · Received June 26, 2000

    Report

    Report Number
    MW1019194
    Event Type
    Malfunction
    Date Received
    June 26, 2000
    Date of Event
    June 21, 2000
    Report Date
    June 26, 2000
    Manufacturer
    THE KENDALL CO.
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RPTR WAS NOTIFIED THAT THE BEDSIDE DRAIN BAGS THAT THEY WERE SUPPLYING HAD A MALFUNCTIONING ANTI-REFLUX VALVE. RPTR TESTED THIS ITEM AND AGREED WITH THE CUSTOMER. RPTR NOTIFIED THE MFR'S REP, WHO CAME HERE ON 6/22/00 AND ALSO AGREED WITH THE CUSTOMER. REP HAS SENT AN EXAMPLE BACK TO KENDALL FOR EVALUATION TO DETERMINE THE NATURE, SEVERITY, AND SCOPE OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL KENGUARD 2 LITER URINARY BEDSIDE DRAIN BAG EYZ THE KENDALL CO. 3512 210542

    Patients

    Seq Age Sex Outcome Treatment
    1 * INDWELLING CATHETER.