BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXO-CATHETER

    MDR report key: 444752 · Received February 14, 2003

    Report

    Report Number
    1417592-2003-00004
    Event Type
    Other
    Date Received
    February 14, 2003
    Date of Event
    January 15, 2003
    Report Date
    February 14, 2003
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE DERMIS ON THE PATIENT'S SKIN BECAME IRRITATED AND THEIR PENIS BECAME SWOLLEN WHILE USING AN EXO-CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXO-CATHETER EXO-CATHETER EXJ MEDLINE INDUSTRIES, INC. DYND12302 640209

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other