Common device name - pouch, colostomy.Complainant was unable to provide the product lot number.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.Although a photograph (s) has been received, no evaluation will 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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It was reported the end user states ¿she feels may have had a urinary tract infection (uti) as a "result of the pouch tail that she was not able to clean adequately." the uti contained e-coli when tested.Uti was treated with antibiotics (no name was provided).The uti was not confirmed to be related to the pouch, which was a sample pouch the end user was trying.End user states she had difficulty cleaning the pouch "as it had to roll up a couple of times, then was fastened shut.There could have been feces that i couldn't see on the tail of the bag or velcro." end user reports she is better now.No further information was provided.
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