Related manufacturer reference number: 1627487-2023-01976.It was reported the patient experienced high fever, chills and severe swelling at the anchor site.In turn, the patient had their system explanted.Results were received and the sites were negative for infection.Patient was prescribed oral antibiotics to address the issue.
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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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