BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MPS EASY RUB FORMULA

    MDR report key: 1592956 · Received January 28, 2010

    Report

    Report Number
    2020664-2009-00076
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    June 17, 2009
    Report Date
    October 14, 2009
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. CHEMISTRY EVAL RESULTS OF RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECIFICATIONS. MICROBIOLOGY EVAL OF RETAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION TO BE STERILE. A VISUAL INSPECTION WAS PERFORMED ON THE COMPLAINT SAMPLE, AND SMALL BLACK PARTICLES WERE FOUND IN THE LIQUID THAT APPEARED TO BE THE REMAINS OF AN INSECT. CHEMISTRY EVAL RESULTS OF EVALUATED PARAMETERS OF THE COMPLAINT UNIT WERE WITHIN ESTABLISHED ACCEPTANCE CRITERIA. THE COMPLAINT UNIT WAS RETURNED BACK ALREADY OPENED AND MICROBIOLOGY RESULTS SHOW THAT THE SAMPLE WAS NOT STERILE. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    A FEMALE CONSUMER REPORTED THAT SHE FOUND HARD LITTLE BLACK PARTICLES ON THE BOTTOM OF A 12 OUNCE RETAIL SIZE BOTTLE OF COMPLETE MULTI-PURPOSE SOLUTION. SHE DID NOT EXPERIENCE ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MPS EASY RUB FORMULA LPN ABBOTT MEDICAL OPTICS, INC. NA AD03331

    Patients

    Seq Age Sex Outcome Treatment
    1