BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE CUP

    MDR report key: 21796551 · Received April 8, 2025

    Report

    Report Number
    MW5168689
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    April 3, 2025
    Report Date
    April 3, 2025
    Manufacturer
    UNKNOWN
    Product Code
    OIE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND, THE GIRL AFTER US, THE GUY AFTER HER AND MYSELF ALL FOUR TOOK A DRUG SCREEN TO GO TO WORK AND ALL FOUR CUPS DID NOT REGISTER THE TEMP. THE NURSE EVEN HAD TO GET A 2ND OPINION. I DON'T KNOW HOW MANY BEFORE OR AFTER US DID THE SAME. THIS CAUSED US NOT TO BE ABLE TO GO TO WORK. REFERENCE REPORTS: MW5168690, MW5168691, MW5168692.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454026 URINE CUP URINE COLLECTION KIT (EXCLUDES HIV TESTING) OIE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female