Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)
|
Event Type
Injury
|
Manufacturer Narrative
|
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 hernia repair surgery on (b)(6) 2006 and mesh was implanted.It was reported that the patient underwent removal surgery and revision surgery on (b)(6) 2016 during which the surgeon noted there was as course of abdominal mesh that was adherent to the anterior abdominal wall and was tightly adherent to the bowel.Due to the mesh, the bowel adhesions were extensive and the surgeon feared more bowel obstructions due to the mesh, so the mesh was removed.It was reported that the patient experienced an unknown adverse event.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: 08/15/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Manufacturer Narrative
|
Date sent to the fda:7/13/2022.Additional b5 narrative: it was reported that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient experienced pain and hernia recurrence.
|
|
Search Alerts/Recalls
|