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-14102021-0001060141 submitted for adverse event which occurred on (b)(6) 2015.Mwr-14102021-0001060142 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) 2011 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2015.It was reported that the patient underwent revision surgery on (b)(6) 2016 during which the surgeon noted that the previously placed mesh had hardened and was tacked only on one side.He was able to envelope the mesh so the hard disc was no longer palpable.It was reported that the patient experienced severe pain, nausea, inflammation, loss of appetite, weakness, stress and anxiety.No additional information was provided.
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