Engineering evaluation was unable to be performed as the electrode was not returned.Allegation is confirmed through images of patient skin irritation and is most probable to be a bio-incompatibility issue with the electrode adhesive.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.
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Patient reported raised bumps, red mark outlining the shape of the patch, burning while using lead wire adapter (lwa).The patient followed the universal patch skin care preparation instructions.The patient has a history of skin sensitives.Patient advised that she did visit the cardiologist on saturday (b)(6), 2023 and was prescribed an ointment for treatment of the burn on her chest.The patient advised that they were wearing the universal patch and not the lead wire adapter when the skin irritation occurred.Patient additionally stated that they had blistering as well as a burn mark under where sensor was placed in the patch.
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