It was reported that, when using exu-dry dressing to treat patients with bio-engineered skin substitutes, one patient reported issues with the prevention of maceration of the dressing.The patient indicated that skin color changed.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.
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H6, the device used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause includes application technique, good wound contact is essential.Daily dressing changes are recommended.No lot/serial number has been provided; therefore, a document review is not possible.A complaint history review was performed and showed other related failures.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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