BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UP AND UP OVULATION TEST

    MDR report key: 6618492 · Received June 3, 2017

    Report

    Report Number
    MW5070212
    Event Type
    Malfunction
    Date Received
    June 3, 2017
    Date of Event
    May 28, 2017
    Report Date
    June 3, 2017
    Manufacturer
    MFR UNK
    Product Code
    NGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UP AND UP BRAND 7 COUNT OVULATION TEST PLUS 1 PREGNANCY TEST. (B)(4). THREE OF THE SEVEN TEST STRIPS APPEAR DEFECTIVE/ NOT WORKING PROPERLY. NO CHANGE/CONTROL APPEARS IN WINDOW. LOT: 2802171.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391232 UP AND UP OVULATION TEST TEST, LUTEINIZING HORONE NGE MFR UNK 359726558075 2802171

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR