BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE PREGNANCY TEST

    MDR report key: 3619191 · Received February 5, 2014

    Report

    Report Number
    MW5034221
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 15, 2014
    Manufacturer
    JANT PHARMOCAL CORP.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT URINE PREGNANCY TEST # 14-008-0054731. RESULT WAS EQUIVOCAL OR UNDETERMINABLE USING JANT PRODUCT # PF864, LOT # 040948, EXPIRATION DATE: (B)(6) 2015. RESULT OF QUANTITATIVE HCG WAS 117,163 MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75779 URINE PREGNANCY TEST URINE PREGNANCY TEST JHI JANT PHARMOCAL CORP. 040948

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other