BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MULTIPURPOSE SOLN EASY RUB FORMULA

    MDR report key: 3871208 · Received April 16, 2014

    Report

    Report Number
    3004537773-2014-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    January 9, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED. REPORTER DID NOT RESPOND TO MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFO AND RETURN OF COMPLAINT SAMPLE. LOT NUMBER AND EXPIRATION DATES WERE NOT PROVIDED. UDI# NOT YET AVAILABLE. LOT NUMBER AND MANUFACTURER DATES ARE UNK. ALL PATIENT INFO AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A CONSUMER THAT HER DAUGHTER PURCHASED TWO BOTTLES OF COMPLETE MULTIPURPOSE SOLUTION EASY RUB FORMULA AND THAT BOTH BOTTLES LEAKED. SHE DID NOT SPECIFY WHERE THEY LEAKED FROM. SHE INDICATED THE SOLUTION DAMAGED A TABLE AND CARPET. SEVERAL ATTEMPTS WERE MADE TO GATHER THE COMPLAINT UNITS AND/OR LOT NUMBERS, BUT THE REPORTER DID NOT RESPOND TO OUR REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233825 COMPLETE MULTIPURPOSE SOLN EASY RUB FORMULA CONTACT LENS DISINFECTION SOLN LPN ABBOTT MEDICAL OPTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1