Model Number PHSM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Pain (1994); 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.(b)(4) submitted for adverse event which occurred on (b)(6) 2007.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted due to umbilical hernia.It was reported that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted due to recurrent umbilical hernia.It was reported that the patient underwent removal of mesh, lysis of adhesions, open repair of recurrent incisional hernia on (b)(6) 2017.It was reported that the patient experienced pain and discomfort.Other procedure is captured under separate file.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: 9/5/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Search Alerts/Recalls
|