Catalog Number PFRA01 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
|
Patient Problems
Unspecified Infection (1930); Other (for use when an appropriate patient code cannot be identified) (2200); Blood Loss (2597); No Code Available (3191)
|
Event Type
Injury
|
Event Description
|
It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been 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
|
Details: it was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2008 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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Manufacturer Narrative
|
(b)(4): it was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2008, and a mesh was implanted due to pop and sui.It was reported that following insertion the patient experienced infection, urinary problems, recurrence, bleeding, dyspareunia and other.No additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).It was reported that the patient underwent a gynecological procedure and mesh was implanted along with concurrent anterior colporrhaphy and cystourethroscopy.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: 06/07/2016.
|
|
Search Alerts/Recalls
|