Catalog Number SPMII |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
Patient Problems
Erosion (1750); Pain (1994); Not Applicable (3189)
|
Event Type
Injury
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2013 and mesh was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision surgery on (b)(6) 2018.No additional information was provided.
|
|
Manufacturer Narrative
|
Patient code: 3191 - cystocele.Additional narrative: it was reported that the patient experienced cystocele and vaginal mesh erosion following the procedure.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
|
|
Manufacturer Narrative
|
Date sent to fda: 7/6/2020.Additional information: a1, d3, e1, g1,g2.Additional b5 narrative: it was reported that the patient experienced pain.
|
|
Search Alerts/Recalls
|