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 the adverse event which occurred on (b)(6) 2019.Mwr-(b)(4) submitted for the adverse event which occurred on (b)(6) 2020.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2019 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted ¿he encountered 20 ml of purulent drainage, which was expressed.There was a loculation of necrotic tissue that was excised along with the hernia sac.There was a tight ball of previous mesh protruding through the fascia.¿ it was reported that the patient experienced severe pain, mesh erosion, nausea, infection, inflammation, weakness, stress and anxiety.The other procedure is captured in a separate file.No additional information was provided.
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