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

Catalog Number	PHY1520R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Nausea (1970)
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 a hernia repair surgery on (b)(6) 2014 and mesh was implanted.The surgeon noted that the mesh had become completely disrupted from the abdominal wall and retracted to one side.The surgeon also noted dense adhesions to the mesh itself.It was reported that the patient continues to experience pain, nausea, inflammation, loss of appetite.No additional information was provided.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT
• 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: 7601439
• Report Number: 2210968-2018-73291
• Device Sequence Number: 1897679
• Product Code: FTL
• UDI-Device Identifier: 10705031132320
• UDI-Public: 10705031132320
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: 07/31/2015
• Device Catalogue Number: PHY1520R
• Device Lot Number: GJ8HQMA0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/14/2018
• 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