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

Model Number PCDH1

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

Patient Problems Diarrhea (1811); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)

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) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2015 during which the surgeon noted after extensive adhesiolysis of over two hours, he noted that the draining fistula was still present, with some of the prosthetic mesh in this location.He cut out the fistula and mesh at a level that did not appear to be part of the inflammatory process.It was reported that the patient underwent removal surgery and revision surgery on (b)(6) 2019 during which the surgeon noted a pocket of infected fluid and discovered deep within he tissue an approximately 10 cm piece of mesh.He drained the fluid and removed the mesh.It was reported that the patient underwent another removal surgery on (b)(6) 2020 during which the surgeon noted he encountered a pocket of murky fluid which led to a thickened area of chronically infected mesh.Removing the mesh in its entirety required him to create a much larger opening in the abdomen.After enhancing the size of the wound, he was able to remove the mesh.It was reported that the patient experienced non-healing wounds, severe pain, bowel obstruction, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.

• Type of Device: 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: 15246731
• MDR Text Key: 298114301
• Report Number: 2210968-2022-06742
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047723
• UDI-Public: 10705031047723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCDH1
• Device Catalogue Number: PCDH1
• Device Lot Number: Z1G601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• 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