The related product was not returned for evaluation, please find below the results of our investigation: we have now concluded our investigation into this complaint.No dhr/batch record review possible as no product code has been made available and no sample was received for evaluation.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.The information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.The investigation did not find product defect or manufacturing process issue.The complaint sample and product code were not available at this time.Once the sample received, an assessment may take place to make further investigation.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.
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