|
Model Number PCDM1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Pain (1994)
|
Event Type
Injury
|
Event Description
|
It was reported by an attorney that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2017.It was reported that the patient experienced severe pain, dense adhesions, stress and anxiety.The patient had a mesh implanted on (b)(6) 2001 which is captured in a separate file.No additional information was provided.
|
|
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.
|
|
Manufacturer Narrative
|
Date sent to the fda: 11/07/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Search Alerts/Recalls
|
|
|