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

Catalog Number PHY1015V

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

Patient Problems Abdominal Pain (1685); Hernia (2240); Injury (2348); 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 hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.Other procedures are captured in a separate file.No additional information is provided.

Manufacturer Narrative

Date sent to the fda: 9/24/2020.Additional information: a1, a2.

Manufacturer Narrative

Date sent to fda: 10/30/2020. .

Manufacturer Narrative

Date sent to the fda: 03/03/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Date sent to the fda: 03/03/2021.Corrected information: g1 - manufacturing site name.

Manufacturer Narrative

Date sent to the fda: 02/23/2021.Additional b5 narrative: it was reported that the patient experienced hernia recurrence, abdominal pain following the procedure.Date sent to the fda: 02/23/2021.Corrected information: d6a.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10345977
• MDR Text Key: 201094719
• Report Number: 2210968-2020-05692
• 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,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: PHY1015V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 117