|
Model Number PVPS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Diarrhea (1811); Nausea (1970); Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
Date sent to fda: 4/12/2021.(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.(b)(4), submitted for adverse event which occurred on (b)(6) 2012.(b)(4), submitted for adverse event which occurred on (b)(6) 2020.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2020.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under separate file.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: 12/15/2021.
|
|
Search Alerts/Recalls
|
|
|