Complaint handling evaluation: dhr review was performed by braemar manufacturing, llc quality assurance, with no contributing factors identified.Ifu provides warning indications for discontinuing use and contacting a medical practitioner or customer service in the event that severe skin irritation occurs.Patient indicated that they are allergic to adhesive and cannot wear any devices that have adhesives.Medical affairs.No additional information is known to braemar manufacturing, llc at this time.
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On 28-may-2019, braemar manufacturing, llc was made aware of patient allegation of burn/skin reaction.The patient wore a c6 patch monitor and contacted their healthcare professional due to an allegation of blisters and skin irritation.The patient indicated to their healthcare professional that the burn/skin irritation is very serious and that it is a third degree burn.The healthcare professional contacted their account executive contact and notified of the event, indicating that they do not believe that the skin irritation/burn is serious.Note: the become aware of the event for lifewatch services, inc.And braemar manufacturing is 28-may-2019, based on notification date by the initial reporter listed.
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