We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been further complaints reported with this failure mode in the past three years.The device was intended for use in treatment.It was reported the print on the pouch was not complete.The photographs provided was inspected which confirmed that one pouch had part of the print missing.This confirmed a relationship between the event and the device.A retained pouch from this lot was reviewed, which confirmed that pouch printing should be clear and without issues.The most likely root cause was found to be an issue with the printer that prints text onto pouches.As the complaint history review found there have been no further complaints from this lot and only one pouch was effected, no further action is deemed necessary.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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