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

Model Number PHY2535V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Obstruction/Occlusion (2422)

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 296370669
• Report Number: 2210968-2022-05783
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132368
• UDI-Public: 10705031132368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female