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

Catalog Number OPHY1010

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); 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 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 a hernia repair surgery on  (b)(6) 2015 and a mesh was implanted.  it was reported that the patient experienced an undisclosed adverse event. it was reported that the patient had revision surgery on (b)(6) 2016.No additional information was provided.

Manufacturer Narrative

It was reported that following insertion the patient experienced pain.

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 OPEN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7138024
• MDR Text Key: 95490601
• Report Number: 2210968-2017-71819
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141560
• 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
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: OPHY1010
• Device Lot Number: JE8GLMA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2018
• Date Device Manufactured: 05/01/2015
• 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: 29 YR
• Patient Weight: 95