The device was not evaluated due to it was not returned for investigation.Investigation results: our investigation into this complaint has now concluded.As of today, no additional information requested or sample for this complaint has become available.Without further information we cannot progress our investigation or confirm the details supplied in this complaint.In the absence of additional information, our investigation remains inconclusive.An investigation into the manufacturing paperwork associated with this product has not been possible due to no lot number being provided.Due to the nature of the reported issue this has been passed to one of our medical specialists who has made the following comments.¿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.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened.Smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.
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