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

Model Number	OPHY1010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Perforation (2001)
Type of Reportable Event	Death
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.
Event or Problem 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.
Additional 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.
Additional 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
• 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: 16142513
• Report Number: 2210968-2023-00282
• Device Sequence Number: 6529473
• Product Code: FTL
• UDI-Device Identifier: 10705031233171
• UDI-Public: 10705031233171
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: OPHY1010
• Device Catalogue Number: OPHY1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 03/15/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/14/2023; 03/16/2023
• 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: Death; Required Intervention
• Patient Sex: Male