It was reported that when the carrier was removed, the silicone adhesive did not remain on the film and removed with the carrier from the film, so it was impossible to use.A backup was available.No delay was reported.The sample will be returned for investigation.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The device used in treatment has been returned and evaluated, establishing a relationship between the event reported.The visual inspection confirmed silicone remained on the carrier, the functional evaluation confirmed reduced adherence, the root cause confirmed as raw material issues.A review of the manufacturing records found that there was no evidence that the product didn't meet specifications at the time of manufacture, complaint history review found other related events.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
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