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, one of these patient presented superficial incision surgical site infection.It is unknown treatment for this complication.
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H3, h6: the device intended for use 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 reported event or determine a root cause.The probable root cause is application ,dressings should be changed around every 3 days but in some cases may be left in place for 7 days.If the adhesive integrity is compromised due to prolonged wear, the surgical site may be susceptible to external contamination.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.No batch/lot number has been provided, therefore a review of the device history has not been possible the complaint history file contains further instances.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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