Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.A separate emdr has been filed under (b)(4) for the second individual mentioned in this case.
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According to the available information, coloplast has initiated a pmcf study as an online survey coordinated by an external partner.When coloplast received the feed-back from the survey an incident was identified, where it was stated that stoma necrosis occurred reportedly related to the use of ostomy rod.According to the available information, this event was related to high compression of mucosa through the rod, resulting in necrosis and edema.Symptoms were bleeding and pain.Overall health impact was chronic pain and reduction of quality of life.Prior health condition: crohn's disease.No further information available to date.
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