Product complaint number: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.An image was received for evaluation and it was determined that foreign matter could be observed which appears to be in the product code needle body.Sxpp1a401.The image is not clear enough to determine what kind of foreign matter is present.No conclusion could be reached as to the cause of the reported complaint.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure it meets required specifications prior to shipment.As part of our quality process, manufacturing records were reviewed for this lot's serial number and manufacturing standards were met prior to the release of this lot.Complaint information will continue to be tracked for potential safety signals through complaint trends as part of post-market surveillance.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength - = 2360 ¿g /m.
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