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

Catalog Number	PHY1520R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This medwatch report is in response to receipt of maude event report mw5078808.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an abdominal hernia repair procedure in 2013 and the mesh was implanted.After a year, the hernia recurred and the patient was having complications like bulging of the hernia and fever.No additional information was requested.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. .

• 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: 7835384
• Report Number: 2210968-2018-75553
• Device Sequence Number: 1271678
• Product Code: FTL
• UDI-Device Identifier: 10705031132320
• UDI-Public: 10705031132320
• Combination Product (Y/N): N
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 12/31/2014
• Device Catalogue Number: PHY1520R
• Device Lot Number: GA8HJKA1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention