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

Catalog Number PCDG1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Vomiting (2144); Discomfort (2330); Fibrosis (3167)

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-(b)(4) submitted for adverse event which occurred on (b)(6) 2015. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2016.

Event Description

It was reported by an attorney that the patient underwent ventral hernia repair surgery on (b)(6) 2007 and mesh was implanted. It was reported that the patient underwent laparoscopic sleeve gastrectomy on (b)(6) 2015 during which the surgeon noted numerous adhesions of omentum to the anterior wall and to the mesh. He performed extensive lysis of adhesions. It was reported that the patient underwent laparoscopic enterolysis on (b)(6) 2015 during which the surgeon noted multiple adhesions of the omentum to the anterior abdominal wall and adhesions of a loop of bowel to the upper third of the mesh, creating a kinking effect. It was noted that a piece of the mesh was stuck to the small bowel. This piece of mesh was separated from the small bowel and explanted. It was reported that the patient underwent diagnostic laparoscopy on (b)(6) 2015 during which the surgeon noted that the small bowel was so severely adherent to the mesh and indurated, requiring resection. The surgeon also noted kinking in the bowel and dense intra-loop adhesions. He explanted to remaining portion of the mesh. It was reported that the patient underwent exploratory laparotomy due to closed loop bowel obstruction on (b)(6) 2016 during which the surgeon noted gangrenous small bowel, multiple inter-loop bowel adhesions, multiple abdominal adhesions and thick scarring. The surgeon performed lysis of adhesions and a small bowel resection. It was reported that the patient underwent ventral hernia repair surgery on (b)(6) 2016. It was reported that the patient experienced recurrent small bowel obstructions, gangrenous bowel, fibrosis fat necrosis, foreign body granulomatous reaction to the mesh, fibrosis, scarring, acute chronic inflammation, abdominal pain and discomfort, nausea and vomiting. No additional information is provided.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 9860892
• MDR Text Key: 193064066
• Report Number: 2210968-2020-02066
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2008
• Device Catalogue Number: PCDG1
• Device Lot Number: ZHG454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/20/2020 Patient Sequence Number: 1