BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITE AID HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM

    MDR report key: 4099533 · Received September 18, 2014

    Report

    Report Number
    2026940-2014-00008
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 18, 2014
    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

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

    Description of Event or Problem · 1

    COMPLAINANT'S MOTHER FILED A COMPLAINT AND STATED THAT AFTER HER SON USED THE MEDICAL DEVICE RITE AID HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM AND EXPERIENCED A BURNING SENSATION IN HIS EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578614 RITE AID HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM LENS CARE SOLUTION LPN KC PHARMACEUTICALS, INC. 121840

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other