MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL ETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT; MESH, SURGICAL

Catalog Number PHY3035R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.This medwatch report is in response to receipt of maude event report mw5067990.

Event Description

It was reported that the patient underwent a ventral incisional hernia repair in 2011 and the mesh was used.Six weeks later the patient was sent to pain management due to continuing serious pain.In 2014 the patient was rushed to er due to incarcerated loop of small bowel within ventral hernia and the mesh was replaced with another like mesh on (b)(6) 2014.It was also reported that the patient can barely walk and now diagnosed with psoriatic arthritis.The patient has been on disability since 2012 and had to go to pain management for seven years.Additional information has been requested.

Manufacturer Narrative

Details: it was reported that the patient underwent a hernia repair surgeries on (b)(6) 2011 and (b)(6) 2014 and physiomesh was implanted during each surgery.It was reported that the patient experienced an undisclosed adverse event.

Manufacturer Narrative

Patient code: (b)(4).It was reported that following insertion the patient experienced small-bowel obstruction and adhesion.

Manufacturer Narrative

In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6465145
• MDR Text Key: 72059787
• Report Number: 2210968-2017-60163
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: PHY3035R
• Device Lot Number: DD8HHDA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 12/04/2017; 03/05/2018; 03/12/2018; 04/25/2018
• Supplement Dates FDA Received: 12/08/2017; 03/30/2018; 04/05/2018; 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 90