BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREEZE 2 CONTROL

    MDR report key: 1780870 · Received July 27, 2010

    Report

    Report Number
    1826988-2010-00490
    Event Type
    Other
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 17, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ADVOCATE ACCIDENTALLY APPLIED BREEZE 2 CONTROL SOLUTION TO HER MOTHER'S EYES. THERE WAS NO ALLEGED ADVERSE REACTION. NO PRODUCT WAS REPLACED AND NO PRODUCT IS RETURNING. ADDITIONAL PRODUCT INFO NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE 2 CONTROL NBW BAYER HEALTHCARE LLC 1489 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK