It was reported that, when using duramax dressing to treat patients with partial thickness burns/superficial burns, removing the dressing was very painful for the patient.The dressing was completely macerated before removal.Then it was easier to remove the dressing.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, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
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H10: 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 and 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.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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