A dhr review was performed, with no contributing factors identified.The affected device (patch) has not been received by lifewatch services, inc.The patient reported sensitive skin / allergy described as allergic to adhesive.The patient was allegedly prescribed a kenalog shot and triamcinolone.1% cream (apply 3x a day).Based on information available the patient only wore the device for one day before experiencing skin irritation symptoms.Skin irritation is a known inherent risk of the device.The mct-1l user guide (sup559 rev.D) includes warning statements stating the following: the mct 1lp is not intended for use on patients with skin or soft tissue damage in the area where the patch is placed (such as burns, irritation, infections, wounds, etc.).If you develop a skin irritation, remove the mct 1l patch and seek medical attention.Reddening or slight irritation of the skin from the mct 1l patch is normal.Contact lifewatch services 1.800.517.6330 if you experience any irritation problems.The patient contacting materials of the patch system have been tested for cytotoxicity, sensitization and skin irritation per the following standards: cytotoxicity iso 10993-5, sensitization iso 10993-10, irritation iso 10993-10.No additional information is known to lifewatch services, inc.At this time.
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