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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Scar Tissue (2060); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent partial removal surgery on (b)(6) 2021 during which the surgeon noted he excised the old scar, removing the chronic wound and following a fistula tract that went from the skin all the way down below the external oblique fascia to the onlay mesh.He removed the portion of the mesh that was exposed and involved with the chronic fistulous tract.Beneath the mesh, there was a chronic cavity.It was reported that the patient underwent removal surgery on (b)(6) 2021 during which the surgeon noted the infection tract led right down to the onlay mesh.When he encountered the mesh, he found it was very adherent and very inflamed.It was fibrosed.He removed most of the onlay mesh, which was particularly problematic because it went right up to the pubic symphysis.It was reported that the patient experienced chronic wound.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 10/25/2022 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) 2021.(b)(4) submitted for adverse event which occurred on (b)(6) 2021.

• Brand Name: PROCEED MESH
• 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: 15671499
• MDR Text Key: 302400422
• Report Number: 2210968-2022-08779
• Device Sequence Number: 1
• Product Code: FTL
• 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: 10/25/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 10/25/2022
• 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: Male