BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MULTIPURPOSE EASY RUB

    MDR report key: 2992321 · Received March 1, 2013

    Report

    Report Number
    3004537773-2013-00003
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS INC 1700 E ST. ANDREW PLACE
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF SOLUTION USED BY PATIENT IS UNKNOWN, AND THE MANUFACTURER DOES NOT HAVE ANY PATIENT INFORMATION THAT WOULD ALLOW US TO FURTHER OUR INVESTIGATION OF LOT NUMBER AND ADVERSE EVENT DETAILS. IT IS UNKNOWN IF THE DEVICE FAILED TO MEET SPECIFICATIONS AS WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO PERFORM PRODUCT INVESTIGATION. THE DEVICE WAS MOST PROBABLY BEING USED FOR TREATMENT, AS THIS TYPE OF DEVICE IS NOT TYPICALLY USED FOR DIAGNOSIS. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT/ADVERSE EVENT IS UNKNOWN. THE COMPLAINANT REPORTED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. HOWEVER, BECAUSE WE HAVE NO RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO GUIDE OUR TESTING, WE HAVE... ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A CONSUMER, WHO IS A NURSE, THAT SHE MET A (B)(6) FEMALE WHO WAS BEING TREATED FOR ACANTHAMOEBA KERATITIS. THE REPORTER WAS AT A TREATMENT FACILITY WHEN SHE MET THE PATIENT. THE PATIENT INDICATED SHE HAD BEEN USING COMPLETE MULTIPURPOSE SOLUTION EASY RUB FORMULA AS PART OF HER LENS CARE REGIMEN. THE REPORTER COULD NOT PROVIDE ANY FURTHER DETAILS. THE REPORTER IS NOT INVOLVED IN THE PATIENT'S CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89460 COMPLETE MULTIPURPOSE EASY RUB LPN ABBOTT MEDICAL OPTICS INC 1700 E ST. ANDREW PLACE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention