It was reported that in a clinical observation of "use of negative-pressure wound dressings to prevent surgical site complications after primary hip arthroplasty: a pilot rct", that the pico negative pressure wound therapy + opsite (smith & nephew) was applied in 76 patients, 2 of these patient presented purulent wound.It is unknown treatment for this complication.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The devices used in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the reported events or determine a root cause.Probable cause includes, dressing left on longer than prescribed or inherent risk of procedure.Medical review concluded, the root cause of the reported purulent wound and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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 batch/lot number has been provided, therefore a review of the device history has not been possible, 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.Case-2020-00010112-4.
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