Universal electrode-patch

Description of Event or Problem

The patient reported skin irritation while using an MCOT device with Universal Patch configuration. The patient experienced general redness, irritation, itching, and bleeding/discharge. The date of the report and when the irritation occurred was not documented. The patient sought medical treatment for the skin irritation and was treated with prescription medication. The patient discontinued service or took a break in service due to the skin irritation. 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

The patient reported skin irritation while using an MCOT device with Universal Patch configuration. The patient experienced general redness, irritation, itching, and bleeding/discharge. The date of the report and when the irritation occurred was not documented. The patient sought medical treatment for the skin irritation and was treated with prescription medication. The patient discontinued service or took a break in service due to the skin irritation. The patient reported following the recommended skin preparation steps and has no history of skin sensitivity or allergies to metals and/or adhesives. The Universal Patch was not returned for evaluation. 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. No single factor or combination factors were identified and/or attributed to electrode skin irritation and associated symptoms. The product labeling advised patient of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.