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) 2020.(b)(4) submitted for adverse event which occurred on (b)(6) 2021.
|
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2020 and mesh was implanted.It was reported that the patient experienced bladder spasms, dyspeunia, incontinence, erosion, and dysuria.It was reported that the patient underwent revision surgery on (b)(6) 2020.It was reported that the patient underwent revision surgery on (b)(6) 2021.No additional information was provided.
|