It was reported that, when using the replicare standard dressing to treat donor sites wounds, one hcp noticed that the patient was developing a pseudomonas colonization in the wound.The wound was aired and the patient started antibiotic therapy.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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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 product and reported event, or determine a root cause.Probable root of the reported infection may be improper preparation of wound area or application of dressing which, if done incorrectly may leave the wound exposed to infection-causing bacteria.No lot/serial number has been provided therefore a review of device history is not possible.A complaint history review found further instances of the reported events.The instructions for use 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.H6: updated codes.
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