Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
|
Patient Problems
Bleeding (1738); Erosion (1750); Pain (1994); Scar Tissue (2060); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)
|
Event Type
Injury
|
Event Description
|
It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2006 and pelvilace to trans-obturator biourethral support system was implanted.It was reported that the patient underwent another gynecological procedure on (b)(6) 2007 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
|
|
Manufacturer Narrative
|
A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Manufacturer Narrative
|
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted due to sui.
|
|
Manufacturer Narrative
|
(b)(4).It was reported that following mesh insertion the patient experienced extrusion, urinary problems, recurrence, bleeding, dyspareunia, and vaginal scarring.No additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).Additional narrative: it was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2007 and a mesh was implanted.It was reported that patient underwent partial removal of vaginal sling, repair of bladder perforation (cystography) on (b)(6) 2007 due to bladder perforation and gross hematuria.It was reported that patient underwent implantation of a transobturator vaginal sling (obtryx tape), cystoscopy on (b)(6) 2007 due to sui, urethral hypermobility.No additional information was provided.
|
|
Search Alerts/Recalls
|