Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Granuloma (1876); Scarring (2061); Not Applicable (3189)
|
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.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and two (2) mesh products were implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted the deep synthetic mesh plug was creating the granulomatous and scarring nature of the right inguinal region.It was reported that the patient experienced an unknown adverse event.No additional information is provided.
|
|
Manufacturer Narrative
|
Date sent to fda: 10/05/2020.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: 4/21/2021.Additional information: a1, a2.
|
|
Search Alerts/Recalls
|