BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 1883800 · Received October 22, 2010

    Report

    Report Number
    1826988-2010-00704
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE ACCIDENTALLY INGESTED A BREEZE2 TEST STRIP WHILE EATING. NO SERIOUS INJURY WAS ALLEGED, BUT THE CUSTOMER WAS ADVISED TO CONTACT HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 NBW BAYER HEALTHCARE, LLC 1440C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK