Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Hernia (2240)
|
Event Type
Injury
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on
(b)(6) 2012 and mesh was implanted during which the surgeon note the previous mesh had rolled up and basically gone through the internal ring partially.It was reported that the patient underwent revision surgery on (b)(6) 2014 during which the surgeon noted there was a wad of mesh in the direct space of the recurrent hernia.This was resected free of the surrounding tissue and discarded.It was reported that the patient experienced pain.It was reported that the patient had a mesh implanted on 2/18/2011 which was captured in a separate file.No additional information was provided.
|
|
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.
|
|
Manufacturer Narrative
|
Date sent to the fda: 10/25/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Search Alerts/Recalls
|