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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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According to the available information, the pharmacy has informed us about a consumer who has used the here complained base plate in (b)(6) 2016.He [she] went to a hospital for treatment.The lesion has been already completely healed.The user has used the here complained item together with coloplast paste (2650) since (b)(6) 2016, the plate was changed on every 3-4th day.The user has noticed her skin became macerated after the 5th plate was removed, she continued with this product, but as the skin became worse (signs of inflammation, very sensible around the stoma) she consulted a doctor who did not prescribed any medicine nor salves, but he recommended to change to sensura click base plate.The skin healed very soon since then, no signs of redness/inflammation etc., the skin is well now.*.
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