BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOP CARE HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM

    MDR report key: 4203060 · Received October 27, 2014

    Report

    Report Number
    2026940-2014-00010
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    November 26, 2014
    Manufacturer
    KC PHARMACEUTICALS, INC.
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT, THE DATE OF EVENT IS BEST ESTIMATED TO BE (B)(+) 2014.

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT, THE DATE OF EVENT IS BEST ESTIMATED TO BE (B)(6) 2014. AWAITING EVALUATION RESULTS.

    Description of Event or Problem · 1

    COMPLAINANT (B)(6) STATED THAT AFTER USING MEDICAL DEVICE TOP CARE HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM, HE EXPERIENCED ISSUES WITH THE BARREL LENS CASE PROVIDED. COMPLAINANT CLAIMS TO HAVE EXPERIENCED DIFFICULTY WHILE TRYING TO REMOVE LENSES FROM BARREL LENS CASE. COMPLAINANT REMOVED THE LENSES AND INSERTED IN HIS EYES, BUT THE RIGHT EYE FELT IRRITATED AND DECIDED TO REMOVE CONTACT. COMPLAINANT NOTICED HE HAD ONLY REMOVED HALF OF THE CONTACT LENS FROM EYE.

    Description of Event or Problem · 1

    INITIAL REPORT WAS SENT ON 10/27/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682402 TOP CARE HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM LPN LPN KC PHARMACEUTICALS, INC. 116552

    Patients

    Seq Age Sex Outcome Treatment
    1 Other