BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI

    MDR report key: 23934755 · Received December 31, 2025

    Report

    Report Number
    3014692331-2025-00001
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 30, 2025
    Manufacturer
    EPITEL
    Product Code
    GXY
    UDI-DI
    00860011072492
    PMA / PMN Number
    K243185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EPITEL ACKNOWLEDGES THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER WEARING REMI SENSORS USING REMI STICKERS. SOME OF THE PATIENT'S SYMPTOMS ARE CONSISTENT WITH MODERATELY SEVERE MEDICAL ADHESIVE-RELATED SKIN INJURY (MARSI) RELATED TO THE REMI STICKER - FOR EXAMPLE, ITCHINESS AND SKIN PEELING (MECHANICAL STRIPPING). HIVES COULD BE A SIGN OF ALLERGIC CONTACT DERMATITIS. THE PATIENT REPORTED A KNOWN ALLERGY TO LATEX, WHICH IS NOT AN INGREDIENT IN REMI STICKER. BASED ON DESCRIPTION BY THE PATIENT, SHE COULD HAVE HAD A TYPE IV CONTACT ALLERGIC DERMATITIS DUE TO AN INGREDIENT IN REMI STICKER SUCH AS ACRYLIC (MOST LIKELY) OR HYDROGEL (UNLIKELY). BASED ON THE DESCRIPTION PROVIDED BY THE PATIENT, SHE WAS VERY LIKELY ADMITTED FOR HER OTHER MORE SERIOUS SYMPTOMS THAT ARE NOT LIKELY RELATED TO A REACTION TO REMI STICKER - CHEST PAIN, NUMBNESS AND TINGLING ALL OVER BODY, FEVER, AND INCREASINGLY FREQUENT SEIZURES. THERE IS NO EVIDENCE OR SUSPICION OF POSSIBLE SEVERE ALLERGIC REACTIONS SUCH AS ANAPHYLAXIS, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, OR ANAPHYLACTIC SHOCK. THERE IS ALSO NO EVIDENCE OR SUSPICION OF BACTERIAL SUPERINFECTION AT THE REMI STICKER SITES. BASED ON EPITEL'S ASSESSMENT OF THE CASE, NO REPORTING CRITERIA WERE MET FOR THIS EVENT. THERE WAS NO DEATH, NO SERIOUS INJURY (INJURY OR ILLNESS THAT IS LIFE-THREATENING, RESULTS IN PERMANENT IMPAIRMENT OR DAMAGE, OR REQUIRES MEDICAL/SURGICAL INTERVENTION TO PREVENT SUCH OUTCOMES), AND NO DEVICE MALFUNCTION. OUR ASSESSMENT IS THAT THE HOSPITALIZATION IN THIS CASE WAS NOT LIKELY DIRECTLY RELATED TO REMI STICKER AND NO MEDICAL INTERVENTION OCCURRED OR WAS NECESSARY TO STABILIZE THE PATIENT OR PREVENT SERIOUS INJURY. THAT SAID, WE ACKNOWLEDGE THAT THERE IS SOME CHANCE THAT THE REACTION TO THE REMI STICKER MAY HAVE CONTRIBUTED TO THE HOSPITALIZATION. GIVEN THAT THE PATIENT WAS HOSPITALIZED FOLLOWING THE REMI SESSION WITH REMI STICKER, WE ARE SUBMITTING A MEDICAL DEVICE REPORT FOR THIS EVENT.

    Description of Event or Problem · 0

    PATIENT REPORTED BEING ADMITTED TO A HOSPITAL. WHILE IN THE HOSPITAL, THE PATIENT REPORTED HIVES, FEVER AND ITCHINESS, CHEST PAINS, NUMBNESS AND TINGLING ALL OVER BODY. THE PATIENT REPORTED SKIN PEELING WHEN THE STICKERS WERE REMOVED, AND FEVER IN ALL THE LOCATIONS THE STICKERS WERE PLACED. THE PATIENT ALSO INDICATED MULTIPLE SEIZURES DURING THE HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792735 REMI CUTANEOUS ELECTRODE GXY EPITEL 20185 Y03182501 00860011072492

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization REMI SENSORS.