MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number PCDG1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862)

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.Mwr-09042021-0000935446 submitted for adverse event which occurred on (b)(6) 2018.Mwr-09042021-0000935447 submitted for adverse event which occurred on (b)(6) 2019.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery and hernia repair surgery in (b)(6) 2019 during which the surgeon noted multiple small hernia defects around the old mesh and the small bowel was densely adherent to the mesh with near bowel to mesh fistula.The mesh was loosened and folding over itself.It was reported that patient had hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient experienced dense adhesions, small bowel to mesh fistula, chronic diarrhea, and chronic and intractable abdominal pain.Other procedure was captured in a separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 4/28/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11654179
• MDR Text Key: 245996769
• Report Number: 2210968-2021-03283
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047716
• UDI-Public: 10705031047716
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• Device Lot Number: DMG331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention