MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM; MESH, SURGICAL, POLYMERIC

Model Number PVPS

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

Patient Problems Inflammation (1932); Pain (1994); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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) 2019.(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 recurrent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent additional surgery on (b)(6) 2019 during which the surgeon noted the prior mesh was protruding.Portions of the protruding mesh and recurrent hernia contents were removed.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted he removed the infected mesh.It was reported that the patient underwent additional surgery on (b)(6) 2020 during which the surgeon noted he found and lysed significant abdominal wall adhesions.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.It was reported that patient had a previous hernia repair surgery on (b)(6) 2010 and mesh was implanted.Other procedure was captured in a separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 06/02/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11098454
• MDR Text Key: 226266284
• Report Number: 2210968-2020-10419
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132412
• UDI-Public: 10705031132412
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Model Number: PVPS
• Device Catalogue Number: XCPVPS
• Device Lot Number: DP8JPGZ0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention