MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH OPEN 10 X 10CM; MESH, SURGICAL, POLYMERIC

Model Number OPHY1010

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

Patient Problems Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Perforation (2001)

Event Type  Death  

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.

Event Description

It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2016 and two mesh products were implanted.It was reported that the patient underwent small bowel resection on (b)(6) 2020 during which the surgeon noted small bowel was damaged when he had to remove those areas of small bowel that had become plastered to the underside of the product.Adhesions were extensive with lots of small bowel plastered to the underside of the previously placed mesh.It was reported that the patient sustained an infection and enterocutaneous fistula from this surgery.It was reported that the patient underwent several additional surgeries to repair a small bowel perforation and the fistula, which required additional small bowel resection.It was reported that the patient died.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 03/16/2023.Additional information: d6.Additional b5 narrative: : it was reported that the death was a result of the mesh implant.

Manufacturer Narrative

Date sent to the fda: 03/14/2023.Additional b5 narrative: it was reported that the death was a result of the mesh implant.

• Brand Name: ETHICON PHYSIOMESH OPEN 10 X 10CM
• 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: 16142513
• MDR Text Key: 307152813
• Report Number: 2210968-2023-00282
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031233171
• UDI-Public: 10705031233171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2023

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
• Device Operator: Health Professional
• Device Model Number: OPHY1010
• Device Catalogue Number: OPHY1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 03/14/2023; 03/15/2023
• Supplement Dates FDA Received: 03/14/2023; 03/16/2023
• 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): Death; Required Intervention
• Patient Sex: Male