Universal electrode-patch

Description of Event or Problem

The patient reported on (b)(6) 2026 that they experienced skin irritation in form of General Redness; Raised Skin ;Rash; Red Bumps-No Open Skin while wearing the MCOT, universal Patch, The patient (pt.) sough medical attention and was prescribed prescription medication but took a break in service (BIS) for the reported event. Additionally, the patient followed skin preparation guidelines and reported skin sensitivity/allergy to metal and adhesives.

Additional Manufacturer Narrative

The patient reported on (b)(6) 2026 that they experienced skin irritation in form of General Redness; Raised Skin ;Rash; Red Bumps-No Open Skin while wearing the MCOT, universal Patch, The patient (pt.) sough medical attention and was prescribed prescription medication but took a break in service (BIS) for the reported event. Additionally, the patient followed skin preparation guidelines and reported skin sensitivity/allergy to metal and 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 Pediatric between 1-18 years old and and has skin sensitivity/allergy to metal and adhesives. The product labeling advised patient of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.