MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT; MESH, SURGICAL, POLYMERIC

Catalog Number PHY2030R

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

Patient Problems Unspecified Infection (1930); 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.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.Mwr-20032019-0000373488 submitted for adverse event which occurred on (b)(6) 2016.Mwr-20032019-0000373499 submitted for adverse event which occurred on (b)(6) 2018.

Event Description

It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent a surgical procedure to irrigate and debride an infected wound on (b)(6) 2016.It was reported that the patient underwent removal surgery of the mesh on (b)(6) 2018 during which the surgeon noted ¿an extensive amount of small bowel adhesions, which took over three hours to lyse, and a bowel perforation.¿ it was reported the patient experienced an undisclosed adverse event.No further information was provided.

Manufacturer Narrative

Additional narrative: it was reported that following the procedure the patient experienced hernia recurrence.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8455678
• MDR Text Key: 139989281
• Report Number: 2210968-2019-79585
• 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
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: PHY2030R
• Device Lot Number: JC8GRGB1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention