It was reported that the patient had an unrelated surgery, following which they developed a staph infection.Patient was brought to operating room on (b)(6) 2020 for debridement and wound closure.Patient is currently on antibiotics, but there is redness, tenderness and swelling at the ipg site.In turn, surgical intervention may take place to address the issue.
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During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.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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