|
Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
|
Patient Problems
Erosion (1750); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)
|
Event Date 01/22/2009 |
Event Type
Injury
|
Event Description
|
It was reported by an attorney that a patient underwent a gynecological procedure on (b)(6) 2007 and a mesh was implanted due to urinary incontinence.The patient suffered from pain and dyspareunia and has undergone various surgical procedures in an attempt to remove the mesh.Patient experiences physical, psychological and emotional pain, suffering and has sustained permanent and debilitating injuries.(b)(4).
|
|
Manufacturer Narrative
|
(b)(4).Conclusion code: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
|
|
Manufacturer Narrative
|
(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2009, and a mesh was implanted due to sui.It was reported that the patient underwent mesh removal on (b)(6) 2010, due to mesh erosion and dyspareunia.It was reported that the patient underwent mesh revision on (b)(6) 2012, due to dyspareunia and vaginal pain.No additional information was provided.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Search Alerts/Recalls
|
|
|