A facility reported a (b)(6) female patient with history of mid-abdominal and right lateral ventral hernia repair with plastic surgery reconstruction ((b)(6) 2021) developed an abdominal infection.The surgeon believe that the patient did not have a graft infection, but she developed necrosis of her abdominal wall at first week follow up after the surgery.She was treated by plastic surgery on (b)(6) 2021.On (b)(6) 2021, a bacterial culture was taken and showed positive for infection.The patient was treated with antibiotics.Product was not removed.
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Surgimend mp (606-206-003) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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