(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on july 21, 2016.(b)(4).
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The end user reported the filter on the pouch scraped her stoma causing slight bleeding.According to the end user, the pouch is transparent and she noted small amount of blood over the stoma.She removed the pouch and washed the area, noting a small quarter inch abrasion on the stoma.There was no more bleeding.
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