MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL, POLYMERIC

Catalog Number PHY1520V

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

Patient Problems Fatigue (1849); Unspecified Infection (1930); Pain (1994); Hernia (2240); No Code Available (3191)

Event Date 10/28/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? reported via maude report #: mw5081196.

Event Description

It was reported by the patient via maude report mw5081196 that the patient underwent abdominal incision hernia surgery on (b)(6) 2011 and mesh was implanted.For the past 5+ years, the patient has experienced many complications including severe pain, constipation, irritable bowel, severe bulging, distended stomach, abdominal infections, chronic fatigue, recurrence of hernia, potential malignancies and tumors, thinning of muscle walls, polycystic, kidney disease.The patient reported that all complications have been well documented by the hospital.The patient reported they are now scheduled for another hernia surgery and was informed by the surgery doctor that there could be severe complications if the mesh is removed.Additional information has been requested.

Manufacturer Narrative

Date sent to fda: 4/11/2019.Constipation, irritable bowel, severe bulging, distended stomach, malignancies, tumors, thinning of muscle walls, polycystic, kidney disease.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8174691
• MDR Text Key: 130674641
• Report Number: 2210968-2018-77841
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: PHY1520V
• Device Lot Number: DE8MGXA0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention