BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTC OCUFOFT LID SCRUB

    MDR report key: 8591326 · Received May 7, 2019

    Report

    Report Number
    MW5086457
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    December 9, 2017
    Report Date
    May 4, 2019
    Manufacturer
    OCUSOFT INC.
    Product Code
    HOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OPHTHALMOLOGIST RECOMMENDED ORIGINAL OTC OCUSOFT LID WIPES TO CLEAN LIDS TO TREAT ASYMPTOMATIC BLEPHARITIS. AFTER TWO USES AS DIRECTED I DEVELOPED A SEVERE ADVERSE REACTION. LIDS BECAME SWOLLEN, RED, AND ITCHY. SINCE REACTION, EYELIDS ARE NOW PERMANENTLY SENSITIZED TO CLEANING. I CAN NO LONGER TOLERATE ANY CLEANING OF THE EYELIDS WITHOUT HAVING A REACTION SUCH AS PAIN AND SWELLING. SINCE USE MY BLEPHARITIS IS NOW CHRONIC AND SYMPTOMATIC ALONG WITH SEVERE CHRONIC DRY EYE. MINOR TRIGGERS, SUCH AS TOUCHING, HEAT, WIND OR READING, NOW CAUSES AN ADVERSE REACTION, SUCH AS IRRITATION, REDNESS, AND LID SWELLING. FREQUENCY: TWICE TO CLEAN LID. HOW WAS IT TAKEN OR USED: TOPICAL. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2017; DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2017. REASON FOR USE: TO CLEAN EYELID MARGINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382711 OTC OCUFOFT LID SCRUB SPONGE, OPHTHALMIC HOZ OCUSOFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability