Section h3, h6: the device was not returned for evaluation, the reported event cannot be confirmed or concluded that the device contributed to the reported event.A documentation has identified no adverse trends and no manufacturing related concerns.The reported event is adequately mitigated and delineated within the instruction for use and risk files.Medical review has concluded, without responses to the documentation/information requests, the clinical root cause of the reported events could not be determined.The pump was tested and was functioning properly upon pickup at the medical facility.The patient reported she ¿believes it was a nursing issue.¿ the patient impact beyond that which has already been reported cannot be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A potential cause may include that the patient was not monitored to ensure that therapy was being applied.The instruction for use gives clear warnings to ensure that the wound site is carefully monitored for signs of infection.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends.
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