Common device name: pouch, colostomy.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: (b)(4).
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The end user had cut wafer stoma opening in 1 out of 10 appliances from a sample pack, at 35-40 mm.Since this was a flexible convex, she stated the appliance moved with her body resulting in the wafer stoma opening cutting her stoma.One-fourth of her stoma protruded and this was the area that was cut.Reportedly, the product was not rough or jagged.She discontinued using the product, returned to a non-company product and the issue resolved without further intervention.Her stoma was oval and measured 35-40 mm.There was no report of stoma obstruction from the product.No photo is available at this time.
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