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

Model Number PCDN1

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Fibrosis (3167); Decreased Appetite (4569)

Event Type  Injury  

Manufacturer Narrative

Date sent to fda: 9/28/2021.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 Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012 during which the surgeon noted upon visualizing the mesh, it became obvious that there was a fibrotic hernia sac just above the umbilical area.This was carefully dissected out and found to have mesh densely adherent to the sac.There was some bowel adherent to the mesh and this was carefully taken down with shad dissection.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The patient had had a previous mesh implanted on (b)(6) 2009 which is captured in separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 12/6/2021.

• 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
• MDR Report Key: 12544730
• MDR Text Key: 273773063
• Report Number: 2210968-2021-08935
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047761
• UDI-Public: 10705031047761
• 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,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCDN1
• Device Catalogue Number: PCDN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2021
• 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
• Patient Age: 52 YR
• Patient Sex: Male