Related manufacturer reference number 1627487-2023-05662, 1627487-2023-05663, 1627487-2023-05847, 1627487-2023-05845, 1627487-2023-05844.It was reported the patient was admitted to the hospital and diagnosed with an infection.The patient's scs system was later explanted because the patient had a fever and pus.
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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.Correction: reportable awareness date on previous report should have been (b)(6) 2023 not (b)(6) 2023.
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