MAUDE Adverse Event Report: EPITEL REMI; CUTANEOUS ELECTRODE

Model Number	20185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: REMI
• Common Device Name: CUTANEOUS ELECTRODE
• Manufacturer (Section D): EPITEL; 465 south 400 east; suite 250; salt lake city UT 84111
• Manufacturer (Section G): EPITEL; 465 south 400 east; suite 250; salt lake city UT 84111
• Manufacturer Contact: william roeca ; 465 south 400 east; suite 250; salt lake city, UT 84111 ; 8014976297
• MDR Report Key: 23934755
• Report Number: 3014692331-2025-00001
• Device Sequence Number: 13123688
• Product Code: GXY
• UDI-Device Identifier: 00860011072492
• UDI-Public: 00860011072492
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K243185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 20185
• Device Catalogue Number: 20185
• Device Lot Number: Y03182501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REMI SENSORS.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female