(b)(4).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.(b)(4).
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The end user reported that on (b)(6) 2021, he visited his local ostomy nurse and she noted a small "scratch" or cut to the tip of the stoma.She treated the area with silver nitrate.The end user was uncertain about what caused the issue but he suspected that it was some time ago when the clip on the pouch got caught in skin and rubbed the stoma, thereby, scratching it.His wear time was 3-4 days.He removed the appliance with plain water and did not use any other products.Reportedly, the patient continued to use the product.No photo is available at this time.
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