Related manufacturer reference number: 1627487-2021-18188, 1627487-2021-18189, 1627487-2021-18191, 1627487-2021-18193.It was reported the patient had an infection at all incision sites.In turn, the patient was prescribed antibiotics to address the issue.Reportedly, the incision sites show signs of healing.
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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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