H3, h6: the device, intended for use in treatment, has been received for evaluation.A visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed that the dressing had reduced bonding capabilities, establishing a relationship with the reported event.The root cause has been identified as a raw material issue.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during production.The device met all specifications upon release into distribution.The complaint history review found further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
|