BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITRATEST PAPER

    MDR report key: 2175256 · Received July 18, 2011

    Report

    Report Number
    MW5021457
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BRISTOL-MYERS SQUIBB COMPANY
    Product Code
    HIO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    LABOR AND DELIVERY NURSE REPORTS MULTIPLE FALSE NEGATIVE RESULTS. MY FEAR IS THAT PRIOR TO RECEIPT, THESE PRODUCTS MAY HAVE BEEN EXPOSED TO/STORED AT EXCESSIVE HIGH TEMPERATURES DUE TO THE CURRENT SEASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITRATEST PAPER PHENAPHTHAZINE PAPER HIO BRISTOL-MYERS SQUIBB COMPANY 8F4601BS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other