BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTMATE NEUTRALIZING TABLETS

    MDR report key: 1672876 · Received April 29, 2010

    Report

    Report Number
    2020664-2010-00014
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 26, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHEET OF THE RETURNED SAMPLE WAS CHECKED FOR APPEARANCE. RESULTS SHOWED THE FOIL HAD BEEN DAMAGED (BENT, TORN). THE TABLETS WERE TESTED FOR CATALASE ACTIVITY AND FOUND NOT TO MEET SHELF LIFE SPECS. RETAINED TABLETS FROM THE SAME LOT WERE ANALYZED AND FOUND TO MEET SPEC.

    Description of Event or Problem · 1

    OUR OFFICE IN (B) (4) REPORTED A FEMALE CONSUMER EXPERIENCED AN OCULAR STINGING SENSATION AFTER USING SOFTMATE DISINFECTING/NEUTRALIZING. THE CONSUMER USED THE FIRST SHEET OF NEUTRALIZING TABLES WITHOUT TROUBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTMATE NEUTRALIZING TABLETS LPN ABBOTT MEDICAL OPTICS, INC NA 22589

    Patients

    Seq Age Sex Outcome Treatment
    1 SOFTMATE DISINFECTING SOLUTION