BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 413685 · Received August 23, 2002

    Report

    Report Number
    413685
    Event Type
    Malfunction
    Date Received
    August 23, 2002
    Date of Event
    August 20, 2002
    Report Date
    August 22, 2002
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    URINARY BAG LEAKING. NO EVIDENCE OF PUNCTURE OR MISUSE; DEFECTIVE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL DRAINAGE BAG EYZ THE KENDALL COMPANY 6300 521500

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other