MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH 15X15Q; MESH, SURGICAL, POLYMERIC

Catalog Number PHY1515Q

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Fistula (1862); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Obstruction/Occlusion (2422); Weight Changes (2607); Decreased Appetite (4569)

Event Type  Injury  

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.

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 on (b)(6) 2018 during which the surgeon noted went along the medial aspect of the stomach where the old pouch, was nothing that the endoscopy had been with what appeared to be mesh material, found that this was again adhered and fistulized to the anterior abdominal wall where the previous mesh was placed.This was taken down and given that we had two areas of concern, one way where the mesh had eroded into the stomach and another way where the fistulous tract was in the fundus, the best plan of action given the gross obstruction of the stomach to perform a total gastrectomy.It was reported the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss.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.Date sent to the fda: (b)(6) 2021.Corrected information: d4 - expiration date.

• Brand Name: PHYSIOMESH 15X15Q
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11362282
• MDR Text Key: 234323936
• Report Number: 2210968-2021-01676
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: PHY1515Q
• Device Lot Number: JB8DDKB1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention