Catalog Number PHSL |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
|
Patient Problems
Pain (1994); Treatment with medication(s) (2571)
|
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent a left groin hernia repair procedure on (b)(6) 2007 and mesh was used.
Approximately (b)(6) weeks after the initial procedure, the patient experienced pain.
The patient underwent a mri to determine the cause of the pain.
The patient reports that the mesh has shrunk and the nerves in the groin have been affected by the mesh.
The patient has had injections to relieve the pain and is currently taking ibuprofen.
|
|
Manufacturer Narrative
|
(b)(4) - pain occurred.
Conclusion: 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).
In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Search Alerts/Recalls
|