BEUDAMED
    FDA Adverse Event Other Summary report: N

    MYCATH, TOUCH-FREE, SELF-CATH

    MDR report key: 515174 · Received March 5, 2004

    Report

    Report Number
    1417592-2004-00002
    Event Type
    Other
    Date Received
    March 5, 2004
    Date of Event
    February 4, 2004
    Report Date
    March 4, 2004
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE PT CONTRACTED A URINARY TRACT INFECTION WHILE UTILIZING THE CATHETER. THE PT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYCATH, TOUCH-FREE, SELF-CATH CATHETER KIT KOD MEDLINE INDUSTRIES, INC. DYND10454 03KA0272

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention