BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCUSOFT LID SCRUB PLUS

    MDR report key: 10355611 · Received July 31, 2020

    Report

    Report Number
    MW5095831
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    July 23, 2020
    Report Date
    July 29, 2020
    Manufacturer
    OCUSOFT, INC
    Product Code
    HOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OPHTHALMOLOGIST ADVISED I USE OCUSOFT PLUS LID SCRUB AND GAVE ME ONE SAMPLE PACKET. I USED IT ON (B)(6) 2020 AT 9PM PER INSTRUCTIONS. WASHED PRODUCT OFF FACE WITH WATER AND GENTLE (B)(6) SOAP ON (B)(6) AT 9AM. ONSET SEVERE ITCHING (B)(6) 2020. ONSET SEVERE PRESEPTAL EDEMA AND FACIAL EDEMA (B)(6) 2020. EDEMA WAS UNCHANGED FOR 3 DAYS DESPITE ORAL LORATADINE; DIPHENHYDRAMINE; TOPICAL CORTISONE OINTMENT 2.5%; COLD COMPRESSES. EDEMA DECREASED BUT STILL PRESENT TODAY, ESPECIALLY ON CHEEKS AND JAW (B)(6) 2020. VISION NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817475 OCUSOFT LID SCRUB PLUS CORNEAL LIGHT SHIELD; EYE DRAIN; LASIK RING; WIPE; WIPE AND WICK HOZ OCUSOFT, INC 5723

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other