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

Catalog Number PHY1515Q

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

Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Hernia (2240); Abdominal Distention (2601); 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 procedure on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent a hernia repair procedure on (b)(6) 2012 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 12/13/2019.

Manufacturer Narrative

Date sent to fda: 1/2/2020.Additional narrative: it was reported that patient underwent removal of mesh on (b)(6) 2016 due to recurrent hernia and adhesion.

Manufacturer Narrative

Date sent to fda: 4/20/2020.Additional narrative: it was reported that following insertion the patient experienced pain, nausea, bloating, constipation, bulging and abdominal wall mass.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8205488
• MDR Text Key: 131702659
• Report Number: 2210968-2018-77792
• 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,Followup,Followup
• Report Date: 12/31/2019

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 Catalogue Number: PHY1515Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/30/2018
• Supplement Dates Manufacturer Received: 11/29/2019; 12/31/2019; 04/19/2020
• Supplement Dates FDA Received: 12/13/2019; 01/02/2020; 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention