The device, used in treatment, have been received for evaluation, establishing a relationship between the reported event.A visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed that the dressing had reduced bonding capabilities.With the root cause, 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.Complaint history for the reported event has been reviewed, revealing further instance which are being monitored to determine if additional corrective actions are required, however this investigation is now complete.
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