Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number, reporting site: 1049092, third party manufacturing site: 3012910884.
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The end user reported skin breakdown and irritation from company's two different products.She was unable to determine what was causing irritation and breakdown from these two products.It had been ongoing for the last three to four months, but she was still using the product.She stated that she had used the company's adhesive remover and barrier wipes prior without any issue.Further, the end user, reported she has seen dermatologist five (05) times for skin irritation and breakdown.In addition to this, consumer reported multiple open areas, denied bleeding at this time and stated some areas were raised and the peristomal skin was painful.She was using ketoconazole cream two (02) times daily, hydrocortisone cream 2.5 as needed (prn), doxycycline two (02) times daily, diflucan two (02) times a week on monday and friday and ciclopirox cream 0.77% two (02) times daily.Further, additional information was received and mentioned that the dermatologist diagnosed the infection as fungal and now, she is using doxycycline two (02) times daily oral for thirty (30) days and using diflucan orally five (05) days a week.All these creams ketoconazole, hydrocortisone, and ciclopirox have been stopped.Treatment is ongoing.She has been seen by wound care.She now washes the peristomal skin with baby shampoo and applies company's known dressing prior to applying ostomy pouch which is improving skin.Further, she was using company's pouch with the wipes when this issue occurred.No other products were used.Now, it is her opinion that she is sensitive to the wipes, and she is no longer using them.A photograph depicting the issue was received from the complainant.
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