BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRIPS,URINE,REAGENT,10SG,100 STRIPS/BT

    MDR report key: 21510398 · Received March 3, 2025

    Report

    Report Number
    1417592-2025-00116
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    January 3, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    JIR
    UDI-DI
    10884389181911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, "ON (B)(6) 2025, 67 Y/O FEMALE INTO THE OFFICE WITH C/O OF URINARY TRACT INFECTION SIGNS AND SYMPTOMS. PATIENT DENIED ANY FEVER BUT WAS C/O PAIN UPON URINATION, BLOOD IN URINE AND STRONG ODOR TO HER URINE. A URINE DIP WAS COMPLETED USING THE URINE REAGENT 10SG 100 STRIPS/BT, WITH THE REF# MPHUA10SG, LOT # 98124030001, WITH EXPIRATION DATE OF 04/10/2026. THE DIP SHOWED POSITIVE FOR BLOOD, PROTEIN AND KETONES. ALL OTHER RESULTS ON STRIP WERE NEGATIVE. OUR PROVIDER SENT THE URINE SAMPLE TO THE LAB WITH AN ORDER FOR UA WITH CNS MICROSCOPIC. IT RESULTED WITH WBC ESTERASE +1, OCCULT BLOOD +1, WBC 11- 30, EPITHELIAL CELLS >10/HPF, CRYSTALS PRESENT, BACTERIA-MANY AND YEAST PRESENT, WITH A RESULT OF ESCHERICHIA COLI. PATIENT WAS STARTED ON MACROBID 100 MG PO BID FOR 5 DAYS, AND EDUCATED ON UTI PREVENTION. PATIENT IS NOW STABLE". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, "ON (B)(6) 2025, 67 Y/O FEMALE INTO THE OFFICE WITH C/O OF URINARY TRACT INFECTION SIGNS AND SYMPTOMS. PATIENT DENIED ANY FEVER BUT WAS C/O PAIN UPON URINATION, BLOOD IN URINE AND STRONG ODOR TO HER URINE. A URINE DIP WAS COMPLETED USING THE URINE REAGENT 10SG 100 STRIPS/BT, WITH THE REF# MPHUA10SG, LOT # 98124030001, WITH EXPIRATION DATE OF 04/10/2026. THE DIP SHOWED POSITIVE FOR BLOOD, PROTEIN AND KETONES. ALL OTHER RESULTS ON STRIP WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165332 STRIPS,URINE,REAGENT,10SG,100 STRIPS/BT JIR MEDLINE INDUSTRIES LP 98124030001 10884389181911

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other