It was reported that during set up, when the carrier was removed, much of the silicone adhesive was removed with the carrier and did not remain on the film, so the opsite flexifix gentle2.5cmx5m could not be used.No delay was reported.No patient involvement.
|
H3, h6: the device was returned for evaluation, confirming the reported event.Visual inspection noted no obvious defects, functional evaluation confirmed silicone remained on the carrier reducing adherence.The root cause has been deemed a component failure, the instructions for use, detail the wound contact layer within these dressing can be affected by storage temperature fluctuations.A documentation investigation has been conducted, confirming that no manufacturing problems have been observed.Complaint history shows previous events of this nature, with corrective actions assigned.The complained product was released after the actions being initiated.The instructions for use and risk files, mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no additional corrective actions deemed necessary.
|