Based on the available information, this event is deemed a serious injury.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.
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End user reports circumferential red, raw and weeping peristomal skin under the white tape collar for past 1 1/2 months.She said the area is painful and itches at times.She reports seeing three different doctors.The first doctor prescribed topicort ointment; the second doctor prescribed clotrimazole betamethasone, and the third doctor prescribed olux-e foam to the affected area.She said he also diagnosed her with an allergic reaction to the white tape collar.
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