The device used in treatment has not been returned for evaluation, but images have been provided establishing a relationship with the reported event.The images confirm dressing has reduced adherence.Probable root cause determined as storage temperature, and or product failure.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.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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