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-27042022-0001173788 submitted for adverse event which occurred on (b)(6) 2013.Mwr-27042022-0001173787 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) 2008 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2013.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2019.It was reported that the patient experienced severe pain, adhesions, nausea, inflammation, loss of appetite, stress and anxiety.No additional information was provided.
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