|
Catalog Number PHY1520V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Necrosis (1971); Seroma (2069); Hernia (2240); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).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.Mwr- (b)(4) submitted for adverse event which occurred on (b)(6) 2014.Mwr- (b)(4) submitted for adverse event which occurred on (b)(6) 2021.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent mesh revisions on (b)(6) 2014 and (b)(6) 2021 due to recurrent ventral hernia, seroma, abdominal pain, adhesions, bulge, discomfort and necrosis.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: 09/27/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Search Alerts/Recalls
|
|
|