MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 7X15CM RECT; MESH, SURGICAL, POLYMERIC

Catalog Number	PHY0715R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Nausea (1970); 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.
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient experienced an undisclosed adverse event.She underwent a recurrent hernia repair on (b)(6) 2016 and mesh was implanted.She was diagnosed with another recurrent hernia in late 2017.It was reported that the patient continues to experience pain, nausea, diarrhea, chills, inflammation, loss of appetite and weight loss.No additional information was provided.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 7X15CM 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: 7264203
• Report Number: 2210968-2018-70813
• Device Sequence Number: 19079624
• Product Code: FTL
• UDI-Device Identifier: 10705031132290
• UDI-Public: 10705031132290
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 04/30/2016
• Device Catalogue Number: PHY0715R
• Device Lot Number: HE8GJRB1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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
• Patient Age: 34 YR