(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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2017, mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2017, mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2017, mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2018, mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2019, mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
|
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and mesh was implanted.It was reported that patient underwent a procedure for excision of eroded mesh on (b)(6) 2018.It was reported that following insertion the patient experienced scar, groin flap and vaginal apical defect.It was reported that the patient has undergone five surgeries related to the vaginal sling repair on (b)(6) 2017, (b)(6) 2018 and (b)(6) 2019.No additional information was provided.
|