Universal electrode-patch

Description of Event or Problem

On (b)(6)2026, the patient reported experiencing general redness and raised skin while using an MCOT device in the Universal Patch configuration with electrodes. The patient sought medical treatment and was treated with prescription medication. The patient discontinued service and will take a break in service (BIS) until a new wearing option arrives. The patient reported following the recommended skin preparation steps and has no history of skin sensitivity or allergies to metals and/or adhesives.

Additional Manufacturer Narrative

On (b)(6)2026, the patient reported experiencing general redness and raised skin while using an MCOT device in the Universal Patch configuration with electrodes. The patient sought medical treatment and was treated with prescription medication. The patient discontinued service and will take a break in service (BIS) until a new wearing option arrives. The patient reported following the recommended skin preparation steps and has no history of skin sensitivity or allergies to metals and/or adhesives. Engineering evaluation was unable to be performed as the universal electrode patch was not returned. The universal patch is single use and disposed after use; therefore, it is not likely to be returned. Any skin irritation is most probable to be a bio-incompatibility issue with the electrode adhesives. Medical Adhesive Related Skin Injury (MARSI) is likely related to a Biocompatibility hazard manifesting at the electrode's interface with the patient's skin. The following factors were identified and/or attributed to electrode skin irritation and associated symptoms. The patient is elderly and over 65 years old and is allergic to adhesives. The product labeling advised patient of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.