BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE DOUBLE MOIST

    MDR report key: 4170587 · Received October 14, 2014

    Report

    Report Number
    3004178847-2014-00008
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: TELEPHONE: (B)(6). (B)(4). PMA510(K): K030092. ALTERNATIVE REPORT IDENTIFICATION NUMBER (B)(4). UNKNOWN SINCE LOT NUMBER IS UNKNOWN PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM OUR OFFICE IN (B)(6) THAT A MOTHER REPORTED HER CHILD (GENDER AND AGE WERE NOT SPECIFIED) EXPERIENCED A SYMPTOM LIKE ANAPHYLAXIS AFTER USING COMPLETE DOUBLE MOIST. THE MOTHER WAS ATTEMPTING TO RETURN THE PRODUCT TO THE STORE WHERE IT WAS PURCHASED. SHE INDICATED THAT SHE TOOK THE CHILD TO A DOCTOR AND THE DOCTOR SAID THE SYMPTOM MIGHT BE DUE TO COMPLETE DOUBLE MOIST. THE RECOMMENDED TREATMENT WAS TO WASH THE CHILD'S EYES WITH PURIFIED WATER. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650813 COMPLETE DOUBLE MOIST SOLUTIONS LPN ABBOTT MEDICAL OPTICS 08941X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other