BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 288447 · Received August 2, 2000

    Report

    Report Number
    MW1019422
    Event Type
    Malfunction
    Date Received
    August 2, 2000
    Date of Event
    July 26, 2000
    Report Date
    July 26, 2000
    Manufacturer
    THE KENDALL CO.
    Product Code
    FCE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    KENDALL ENEMA BAG USED TO ADMINISTER TAP WATER ENEMA PRIOR TO COLONOSCOPY. DURING THE PROCEDURE RECTAL ABRASIONS NOTED AT APPROXIMATELY 10 CM. ABRASIONS NOTED ON PRIOR PTS WITH SIMILAR PROCEDURES. ENEMA BAG TUBING HAS SHARP INNER SURFACE ON INSERTION END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL SEAMLESS ENEMA BAG FCE THE KENDALL CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other