BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 2323472 · Received October 28, 2011

    Report

    Report Number
    1826988-2011-00629
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    October 5, 2011
    Report Date
    October 5, 2011
    Manufacturer
    BAYER HEATLHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER ACCIDENTALLY PUT BREEZE2 CONTROL SOLUTION INTO HER EYES THINKING IT WAS THE MEDICATION FOR HER EYE SURGERY. THE CUSTOMER CONTACTED HER DOCTOR. THE DOCTOR DID NOT THINK THERE SHOULD BE ANY PROBLEMS SINCE THE SOLUTION DOES NOT CONTAIN ALCOHOL. NO MEDICAL TREATMENT WAS REQUIRED. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK