It was reported that one patient treated with renasys indicated that the wound deteriorated after using the device.Local infection and redness leading to suspicion of infection exacerbation were discovered, and led to protracted wound healing.It was unknown if/how the problem was solved.This information was reported via a retrospective post market clinical follow up activity (pmcf) on the use of renasys system to treat skin grafts.This was carried out by an external vendor, appointed by s+n, who gathered anonymised data from hcps via an online form.As this data collection activity has been done retrospectively, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
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The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause include application technique, good wound contact is essential.Daily dressing changes are recommended.No lot/serial number has been provided, therefore a review of the device history is not possible.A complaint history review found further instances of the reported event.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 + nephew will continue to monitor for any adverse trends relating to this product range.
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