Related manufacturer report number: 3006705815-2022-14788, 3006705815-2022-14789, 1627487-2022-03172.It was reported that the patient's wound had reopened after a procedure on (b)(6) 2022 (manufacture report number: 3006705815-2022-01289), as a result the patient underwent additional surgery to address the issue.
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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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