BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSOM CARD PREGNANCY TEST

    MDR report key: 5963461 · Received September 20, 2016

    Report

    Report Number
    5963461
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 5, 2016
    Report Date
    August 18, 2016
    Manufacturer
    SEKISUI DIAGNOSTICS, LLC
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONTROL LINE ON THE URINE PREGNANCY TEST DID NOT SHOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616153 OSOM CARD PREGNANCY TEST VISUAL, PREGNANCY JHI SEKISUI DIAGNOSTICS, LLC 151478

    Patients

    Seq Age Sex Outcome Treatment
    1