BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URS - IK URINALYSIS STRIPS

    MDR report key: 442038 · Received February 5, 2003

    Report

    Report Number
    MW1027476
    Event Type
    Injury
    Date Received
    February 5, 2003
    Date of Event
    December 1, 2002
    Report Date
    January 26, 2003
    Manufacturer
    L.W. SCIENTIFIC, INC.
    Product Code
    JIL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    URINE KETONE STRIPS READING FALSE POSITIVE THAT LEAD TO HOSPITALIZATION OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URS - IK URINALYSIS STRIPS URINE REAGENT STRIPS JIL L.W. SCIENTIFIC, INC. * B10078
    2 URS - IK URINALYSIS STRIPS URINE REAGENT STRIPS JIL L.W. SCIENTIFIC, INC. * C10563

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization