BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4173505

    MDR report key: 279546 · Received May 30, 2000

    Report

    Report Number
    1718873-2000-00007
    Event Type
    Injury
    Date Received
    May 30, 2000
    Date of Event
    April 27, 2000
    Report Date
    May 30, 2000
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATHETER BROKE AT SUTURE LINE AFTER 8 HOURS OF USE. THE CATHETER BROKE WHEN REPOSITIONING THE CATHETER. THE BREAK WAS AT OR AROUND THE SUTURE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4173505 UVC, CATH SILICON, 3.5 FRENCH FOS UTAH MEDICAL PRODUCTS, INC. NA 10027-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention