|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
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 removal surgery and recurrent hernia repair surgery on (b)(6) 2019 and the mesh was implanted during which the surgeon lysed the adhesion to the mesh and removed the mesh.It was reported that the patient had hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient had cholecystectomy on (b)(6) 2018 due to adhesion and splenectomy on (b)(6) 2018 due to adhesion.It was reported that the patient experienced an unknown event.Other procedure was captured in a separate file.No additional information was provided.
|
|
Search Alerts/Recalls
|
|
|