Date sent to fda: 03/16/2018.(b)(4) surgical intervention.(b)(4) no code available.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.
|
It was reported by an attorney that the patient underwent a gynecological surgical procedure to treat vaginal vault prolapse on (b)(6) 2016 and mesh was implanted.It was reported that she experienced pain, infections and required additional medical and surgical treatment, including a mesh removal surgery on (b)(6) 2016 at (b)(6).No additional information was provided.
|