A review of the complaint device history records, indicated that the patch was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.A visual inspection of the returned product was performed by our quality assurance (qa) manager.The product box was opened (broken seal) and contained only the patient labels set and the instructions-for-use: the device and primary packaging were missing.The product, as it was received, was not meeting its specification.However, the cause of the event remains unknown.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.No conclusion could be drawn.The conducted investigation would tend to indicate that the device was not defective at the time of manufacturing.It is highly unlikely that an omission has occurred during the packaging stage because each component is scanned individually.However, a non-conformity report has been initiated in order to further investigate the event and take appropriate corrective actions if necessary.
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When the box was opened, the patch was missing, the only thing inside was the ifu and the labels.The box was not opened before, the customer is 100% sure and is using the product on a regular basis.No harm to patient involved and the surgeon was not aware of the incident, they had 4 more boxes on the shelf.
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