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

Catalog Number PHY2025V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Hernia (2240); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500 form.

Event Description

It was reported by an attorney that the patient underwent a repair of an incarcerated ventral hernia on (b)(6) 2014 and mesh was implanted.On (b)(6) 2015 the patient underwent an invasive surgical procedure at (b)(6) hospital in (b)(6), for recurrence of his  incarcerated large and small bowel ventral hernia and removal of the mesh.It was reported that the physician noted that the mesh was protruding into the hernia sac with omental adhesions, necessitating removal of the mesh as well as additional surgical repair of the same hernia it was implanted to treat.

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.

Manufacturer Narrative

Date sent to fda: 7/4/2019.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7155732
• MDR Text Key: 96109233
• Report Number: 2210968-2017-72043
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: PHY2025V
• Device Lot Number: HE8GCWB0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2019
• Date Device Manufactured: 05/01/2014
• 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: 47 YR
• Patient Weight: 156