BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP PEROXIDE (PLATINUM)

    MDR report key: 4862778 · Received June 23, 2015

    Report

    Report Number
    9615939-2015-01005
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    June 22, 2015
    Manufacturer
    SAUFLON PHARMACEUTICALS, LTD
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT LENS SOLUTION WAS NOT RETURNED FOR INSPECTION. THE COMPLAINT IS UNCONFIRMED. THE ASSOCIATION BETWEEN THE CONTACT LENS SOLUTION AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    DATE OF EVENT IS UNKNOWN. A LIST OF COMPLAINTS WAS SENT TO COOPERVISION INC FROM (B)(6), THIS DOCUMENTS A CONSUMER COMPLAINT STATING THAT USE OF THE ONE STEP PEROXIDE SYSTEM CAUSED AN ALLERGIC REACTION. PATIENT ALLEGES, "IN THE MIDDLE OF TREATMENT", AND HAS TO GO BACK SO THAT, "EYES NO LONGER HURT". THIS EVENT IS BEING REPORTED IN ABUNDANCE OF CAUTION BASED ON THE PATIENT ALLEGATION OF MEDICAL INTERVENTION. IT IS UNKNOWN WHAT "TREATMENT" ENTAILS AND/OR WHAT ACTIONS WERE TAKEN TO PREVENT OR TREAT A PERMANENT INJURY. NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED AND THEREFORE THIS IS SUBMITTED AS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405315 ONE STEP PEROXIDE (PLATINUM) MULTI LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other