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 number provided, there have been further complaints reported with this issue in the past four years.It was reported that the product was used for treatment in which the dressings were found to have low adhesion.As no samples were returned, a functional evaluation was not possible.However, images received show the dressing was not fully adhered.This confirmed a relationship between the event and the device.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.The root cause was determined as manufacturing process error.As this is a low occurring issue and controls are in place to monitor this issue, 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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