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

Catalog Number PHY2025V

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

Patient Problems 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 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 laparoscopic ventral incisional hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent laparoscopic repair of ventral hernia on (b)(6) 2015 due to hernia recurrence.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 09/15/2020.

Manufacturer Narrative

Date sent to the fda: 07/07/2021.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10455382
• MDR Text Key: 204415403
• Report Number: 2210968-2020-06377
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHY2025V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention