It was reported that during set up and inspection when the opsite carrier was removed, much of the silicone adhesive was removed with the carrier and did not remain on the film, so it could not be used; the procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
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The device was not used in treatment hasn't been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the reported event or determine a root cause on this occasion.Probable root cause include, raw material issue, the ifu offers further guidance.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture, the complaint history file contains further instances of the reported event.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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