|
Model Number PHSE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Numbness (2415); 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.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2019 during which the surgeon noted that the old mesh was adherent to the ilioinguinal nerve and other structures in the groin.He also observed mesh that appeared to be crinkled, compressed, contracted or folded in areas.It was reported that the patient experienced severe pain, numbness, tingling sensation, impaired sexual relations, stress and anxiety.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: (b)(6) 2021.Additional information: d4, h4.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: 11/14/2021.
|
|
Search Alerts/Recalls
|
|
|