MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL, POLYMERIC

Catalog Number	PHY1520V
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional 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 device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
Event or Problem Description
It was reported by an attorney that the patient underwent surgery to repair an incarcerated ventral incisional hernia on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal of a portion of the mesh on (b)(6) 2014 and the surgeon note the mesh was ¿markedly attenuated with some recurrent herniations centrally with mesh failure.¿ it was reported the patient continues to experience severe pain, bloating, diarrhea and constipation.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 6/21/2019.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7659972
• Report Number: 2210968-2018-73962
• Device Sequence Number: 13498689
• Product Code: FTL
• UDI-Device Identifier: 10705031132337
• UDI-Public: 10705031132337
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: PHY1520V
• Device Lot Number: ED8BDWA0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention