BEUDAMED
    FDA Adverse Event Summary report: N

    IRRIATION TRAY

    MDR report key: 363514 · Received November 29, 2001

    Report

    Report Number
    9612030-2001-00012
    Date Received
    November 29, 2001
    Report Date
    November 29, 2001
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT ALLEGING RPODUCT ALLEGIANCE DISTRIBUTED TO CHOICE MEDICAL SUPPLIES INC. CAUSED INFECTION IN THE END USER. THE PRODUCT, BAXTER FOLEY CATHETERIZATION TRAY, WAS PRIVATE LABELED BY KENDALL. KENDALL MADE AWARE OF COMPLAINT ON 11/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53868 IRRIATION TRAY * KOD THE KENDALL COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other