H3, h6: the batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review found a small number of similar instances of the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence.The device was not used for treatment and was returned for analysis.The roll was creased and was coming away from the carrier paper at one side, thus establishing a relationship between the event and the device.It has not been possible to identify a definitive root cause.Probable root cause is damaged caused during the packing of the roll within the carton during manufacture.Quality checks are in place to prevent damaged goods leaving the production site and so this may be as a result of a missed quality check.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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