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

Catalog Number	PHY1520V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932)
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 further reported by an attorney that patient underwent recurrent hernia repair surgery on (b)(6) 2011 and adhesions to the anterior abdominal wall were noted and a mesh was implanted.It was reported that the patient again underwent surgery to repair recurrent incisional hernia on (b)(6) 2012 and extensive adhesions to the anterior abdominal wall and ¿to the old mesh¿.  the mesh was pulled away from the fascia in the left lower quadrant with small hernia and another mesh was implanted.It was further reported the patient underwent surgery on (b)(6) 2016 to debride and excise abdominal wall tumor (scars, foreign bodies and hernia materials), complex abdominal wall and hernia advancement repair.  it was reported the patient underwent removal of old infected mesh on (b)(6) 2017 and then additional surgery on (b)(6) 2017 to explore, debride and remove old infected mesh, explant mesh from liver, control of liver lacerations and bleeding, complex multiple flaps and abdominal repair.  it was noted the plastic mesh was firmly adherent to the preperitoneal fat  and endoabdominal fascia.It was reported the mesh had either pinfolded or had folded on itself and crinkled, creating an inflammatory mass and portions were embedded on the liver.  it was also reported patient continues to experience severe pain, multiple revision surgeries, organ damage, disfigurement, scarring, infection, seroma, nausea, diarrhea, chills, inflammation, loss of appetite and weight loss.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 07/10/2019.

• 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: 7683061
• Report Number: 2210968-2018-74310
• Device Sequence Number: 13834970
• Product Code: FTL
• UDI-Device Identifier: 10705031132337
• UDI-Public: 10705031132337
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 06/30/2013
• Device Catalogue Number: PHY1520V
• Device Lot Number: DH8CHMA0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention