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 issues highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint 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.It was reported that the dressings were used for treatment and creasing was found on the film.The returned dressings were disassembled so it was not possible to perform a product evaluation.There are checks in place to prevent creasing of the film.If creasing is identified during in-process checks, it is tabbed and recorded in the fault log.Minor creasing can sometimes occur in the film during the adhesive application process at the start or end of the roll.Again visual checks are in place to identify this.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.However, we will continue to monitor for any adverse trends relating to this product range.
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