Model Number PHSE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330)
|
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) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2021 during which the surgeon noted it was densely adherent to the undersurface of the external oblique which he dissected.He found that the mesh had pulled away from the distal shelving and then dissected the entire mesh.While removing a piece of mesh, a small branch of the interior epigastric artery was torn and needed to be repaired.He then repaired the recurrent hernia.It was reported that the patient experienced severe pain.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.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2021 during which the surgeon noted it was densely adherent to the undersurface of the external oblique which he dissected.He found that the mesh had pulled away from the distal shelving and then dissected the entire mesh.While removing a piece of mesh, a small branch of the interior epigastric artery was torn and needed to be repaired.He then repaired the recurrent hernia.It was reported that the patient experienced severe pain.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: 6/7/2022.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: 5/24/2022.Additional b5 narrative: it was reported that the patient experienced nerve entrapment, discomfort and scar tissue following surgery.
|
|
Search Alerts/Recalls
|