No samples were received for review or testing.A review of the device history record and sterilization records for this particular lot confirmed there were no quality issues noted and the devices met all specified requirements for this size/type barbed suture device.Without receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, post-operative instructions or events that may have occurred and/or contributed to the reports of infection/skin reactions, a definitive root cause cannot be determined at this time.
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