It was reported that during wound treatment with replicare thin dress 3.5x5.5in, on follow up visit, substantial excoriation was noted on one patient.The usage of the dressing was suspended immediately.The treatment was completed using a vac therapy, and the patient received steroids and antifungal oral medications to treat the excoriation.No other complications were reported.
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H3, h6: the device, was not returned for evaluation, all provided information has been reviewed and we have not been able to confirm the reported event.Medical review concluded, he information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities).The ifu highlights that the dressing should not be used on patients with known sensitivities.It was further communicated, the use of the replicare thin dress was suspended immediately and the treatment was completed using vac therapy, steroids, and an antifungal oral medication for the excoriation.In addition, an extra layer of cavilon skin protectant was used as the peri-wound healed.Since no other complications were reported, no further medical assessment is warranted at this time.A documentation review has been conducted, confirming previous complaints of this nature.No historical escalations or manufacturing problems were observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.
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