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

Model Number PCDG1

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Hematoma (1884); Inflammation (1932); Nausea (1970); Pain (1994); Perforation (2001); 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) 2010.(b)(4) submitted for adverse event which occurred on (b)(6) 2010.

Event Description

It was reported that the patient underwent removal surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted significant blood superior to the mesh.The mesh was removed exposing a large hematoma, which was evacuated.It was reported that the patient underwent removal surgery on (b)(6) 2010 during which the surgeon noted there were loops of bowel adherent to the mesh, the lysing of which resulted in perforation of the bowel.The contaminated mesh was removed with great care to cause the least amount of trauma to the abdominal wall as possible.It was reported that the patient underwent a surgical procedure on (b)(6) 2010.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The patient had a previous mesh implanted on (b)(6) 2009 which is captured in separate file.Other procedure is captured under separate file.No additional information was provided.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12741723
• MDR Text Key: 282112479
• Report Number: 2210968-2021-10783
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047716
• UDI-Public: 10705031047716
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• 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