MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number	PCDW1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Pain (1994); Scar Tissue (2060)
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.
Event or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted he found chronically incarcerated omentum that was densely adherent to the surrounding tissues.Once they had circumferentially dissected this out and opened up the old mesh, making 1 opening, they carefully dissected out of the omentum from its chronic incarceration.They encountered another layer of very scarred in mesh that had fallen down away from the fascia and was completely separate from any other structure aside from the omentum, which was encased within.This required a very extensive and time consuming dissection that as well over 3 times the expected amount of time to perform this procedure.They then very carefully dissected away adhesions to the fascia.This included omentum, colon and small bowel.There were several adhesive bands and 1 very dense adhesion of the terminal ileum to the right lower quadrant abdominal wall, most likely from her hernia repair that severely narrowed the lumen of the small bowel.The colon was then carefully dissected free from the oldest piece of mesh that was freely floating in the abdomen encased with omentum.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15741616
• Report Number: 2210968-2022-09181
• Device Sequence Number: 12546029
• Product Code: FTL
• UDI-Device Identifier: 10705031047792
• UDI-Public: 10705031047792
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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
• Report Date (Section B): 11/06/2022

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: PCDW1
• Device Catalogue Number: PCDW1
• Device Lot Number: ELG360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/06/2022
• 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