Date of event is estimated.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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Related manufacturer reference number: 1627487-2021-17241, related manufacturer reference number: 1627487-2021-17242, related manufacturer reference number: 1627487-2021-17243, related manufacturer reference number: 1627487-2021-17244.It was reported that patient experienced pus, bleeding and foul-smelling drainage from the incision sites.Infection was suspected by the physician.As a result, to address the issue the entire system was explanted.Treatment of antibiotics was given post op.
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