Related manufacturer report number: 3006705815-2022-00131, 3006705815-2022-00132, 3006705815-2022-00133, 1627487-2022-00181.It was reported the patient had their system explanted due to an infection.The location of the infection is unknown.The patient was given iv and oral meds.The infection has resolved.
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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