BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORALMEDIC

    MDR report key: 22070103 · Received May 22, 2025

    Report

    Report Number
    MW5170707
    Event Type
    Injury
    Date Received
    May 22, 2025
    Report Date
    June 5, 2025
    Manufacturer
    EPIEN MEDICAL, INC.
    Product Code
    NEC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADD'L INFO RECEIVED FOR REPORT # MW5170707 ON 06/05/2025 TO CORRECT THE PROCODE.

    Description of Event or Problem · 0

    I SUFFER FROM RECURRENT, EXTREMELY PAINFUL ORAL ULCERS (CANKER SORES). FOR YEARS, ORALMEDIC (ALSO KNOWN AS HYBENX) WAS THE ONLY TREATMENT THAT EFFECTIVELY STOPPED THE PAIN AND ACCELERATED HEALING. SINCE IT'S DISCONTINUATION, I HAVE EXPERIENCED SEVERE, ONGOING PAIN, DIFFICULTY EATING, DRINKING, SPEAKING, AND SLEEPING. NO ALTERNATIVE TREATMENT HAS WORKED FOR ME. I'VE TRIED EVERY AVAILABLE OVER-THE-COUNTER OPTION; MY HEALTH PROFESSIONAL HAS TOLD ME THAT THERE ARE NO OTHER PRESCRIPTION ALTERNATIVES. THE ABSENCE OF ORALMEDIC HAS RESULTED IN RECURRENT SUFFERING WITH NO RELIEF. THE DISCONTINUATION OF THIS PRODUCT HAS LEFT ME AND OTHERS WITH NO EFFECTIVE OPTIONS, AND IT HAS SIGNIFICANTLY IMPACTED MY HEALTH, NUTRITION, AND QUALITY OF LIFE. I LITERALLY CANNOT EAT WHEN HAVING THIS ISSUE. I'M ASKING THAT THE FDA TAKE NOTE OF THE HARM THIS HAS CAUSED AND CONSIDER STEPS TO ENCOURAGE ITS RETURN OR FACILITATE ACCESS THROUGH COMPASSIONATE USE OR COMPOUNDED ALTERNATIVES. PLEASE HELP ME AND OTHERS. THIS IS A VERY PAINFUL SITUATION AND IT'S ACTIVELY HARMING ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367747 ORALMEDIC BANDAGE, LIQUID, SKIN PROTECTANT NEC EPIEN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability