To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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It was reported that the patient underwent hernia repair surgery on (b)(6) 2019 and mesh was implanted.It was reported that the patient underwent abdominal wound exploration with debridement of umbilical sinus on (b)(6) 2020.It was reported that the patient underwent fluid evacuation and irrigation on (b)(6) 2020.It was reported that the patient underwent removal surgery on (b)(6) 2020.It was reported that the patient experienced severe pain, infection, drainage, nausea, inflammation, loss of appetite, stress and anxiety.No additional information was provided.
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