(b)(4).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.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.(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) 2014 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2018 at which time the mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2019.It was reported the patient experienced pain, inflammation, scarring, bulging mass, and neurectomy of genital branch of genitofemoral nerve.No additional information was provided.
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