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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2017.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2017.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011.And mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2017.And mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2017.And mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted the mesh had torn and had a hernia through it.He removed a portion of the mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.Other procedures are captured in separate files.
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