It was reported that, when using opsite flexifix gentle for protecting the skin from friction and external contamination on patients, it was reported that when it sticks together a lot, there are skin injuries when it is peeled off.It is unknown how the injuries were treated.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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H3, h6: 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 causes may include, application, removal, time left on patient, trauma, materials used within the dressing.The instructions for use provide comprehensive instructions of the operation, use and limitations 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.No lot/serial number has been provided, therefore a review is not possible.A complaint history review found other related events.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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