BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITE AID CLEANING AND DISINFECTING LENS CARE SYSTEM

    MDR report key: 3197309 · Received June 28, 2013

    Report

    Report Number
    2026940-2013-00004
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 1, 2013
    Manufacturer
    KC PHARMACEUTICALS, INC.
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT, (B)(6) 2013, IS THE BEST ESTIMATE SINCE THE ORIGINAL DATE OF EVENT COULD NOT BE ACQUIRED. COMPLAINT SAMPLE COULD NOT BE RETRIEVED.

    Description of Event or Problem · 1

    ONE (1) PATIENT ((B)(6)) STATES THAT SHE EXPERIENCED A BURNING SENSATION IN HER EYES AFTER USING A MEDICAL DEVICE, RITE AID CLEANING AND DISINFECTING LENS CARE SYSTEM. THE PATIENT 'S MEDICAL RECORD IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296387 RITE AID CLEANING AND DISINFECTING LENS CARE SYSTEM LENS CARE SOLUTION LPN KC PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other