Common device name: pouch, colostomy.Based on the available information, this event is deemed to be a serious injury.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.Additional patient / event details have been requested but, not provided to date.The lot number was not provided.Should additional information become available a follow-up report will be submitted.(b)(4).
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It was reported open sore to the left side of her stoma that towards umbilicus, that became very painful.It was described as open ulcer at 3 o¿clock, approximately ¾¿ in diameter and extends from side wall of stoma to peristomal skin.She also has a raw area on the right side of her stoma at 9 o¿clock, that had not progressed to an open sore.She went to the emergency room on (b)(6) 2019 and was diagnosed with cellulitis, and given a prescription for keflex.She then had a follow up with her surgeon, and was seen by an ostomy nurse at the surgeon¿s office on (b)(6) 2019, who instructed her to crust the areas, and recommended she switch to esteem + one piece drainable pouch with moldable barrier.She further reports she has almost completed the keflex, the open ulcer at 3 o¿clock is no longer painful, and the raw area at 9 o¿clock has almost fully resolved.The end user informed at the time of her ileostomy surgery her stoma was 35mm and she was wearing esteem+ flex convex.Over the last few months, her stoma has prolapsed and the diameter has increased to 38mm.She continued to wear the esteem+ flex convex but, reported that she was cutting the opening beyond the maximum cutting surface.The end user was instructed to avoid convexity, and not to cut beyond the maximum cutting surface marked on any pouch barriers.No photographs were provided.
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