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) 2015.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2016.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2016.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, dense adhesions to bowel, adhesions and extreme weight loss.The other procedure is captured in a separate file.No additional information was provided.
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