MAUDE Adverse Event Report: ETHICON INC. PHY2535V; MESH, SURGICAL, POLYMERIC

Model Number	PHY2535V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2016.
Event or Problem Description
It was reported by an attorney that the patient underwent a ventral hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent an incisional hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent an incisional hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 and (b)(6) 2016.It was reported that the patient experienced pain, nausea, diarrhea, chills, inflammation and other undisclosed adverse events.Other procedures are captured under separate files.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 04/16/2023.Additional b5 narrative: it was reported that the patient experienced mesh infection, small bowel obstruction and small amount of fluid.

• Brand Name: PHY2535V
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15081041
• Report Number: 2210968-2022-05783
• Device Sequence Number: 3953821
• Product Code: FTL
• UDI-Device Identifier: 10705031132368
• UDI-Public: 10705031132368
• 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
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Model Number: PHY2535V
• Device Catalogue Number: PHY2535V
• Device Lot Number: GD8JJJAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 04/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female