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); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Foreign Body In Patient (2687); 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.Mwr-22032022-0001152157 submitted for adverse event which occurred on (b)(6) 2012.Mwr-22032022-0001152156 submitted for adverse event which occurred on (b)(6) 2013.Mwr-22032022-0001152155 submitted for adverse event which occurred on (b)(6) 2016.Mwr-22032022-0001152154 submitted for adverse event which occurred on (b)(6) 2018.

Event Description

It was reported by an attorney that the patient underwent recurrent hernia repair surgery on (b)(6) 2012 and mesh was implanted during which the surgeon noted a defect was noted in the inferior/lateral aspect where the mesh was not adhered to the abdominal wall.It was reported that the patient underwent revision surgery on (b)(6)2012 during which the surgeon noted the mesh was palpated inferiorly and seemed to have pulled away in this area.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2013 and mesh was implanted during which the surgeon noted we did encounter a couple different layers of mesh in this area.It was inferiorly again where this appeared to have pulled free.Anteriorly, the mesh was identified as a thickened very fibrotic mass.Eventually during the procedure, we ended up removing pretty much all of this in its entirety.It was reported that the patient underwent removal surgery on (b)(6) 2016 during which the surgeon noted the mesh was identified in the lower abdomen and there was bowel adherent to the mesh and the pro-tak coils.A lysis of adhesions was done circumferentially to free the bowel from the mesh.The mesh and all foreign material was removed from the abdomen.It was reported that the patient underwent removal surgery on (b)(6) 2018.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.It was reported that the patient had hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient had hernia repair surgery on (b)(6) 2011 and mesh was implanted.Other procedure is captured under separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 5/1/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• 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: 13866284
• MDR Text Key: 289102810
• Report Number: 2210968-2022-02072
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047716
• UDI-Public: 10705031047716
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• Device Lot Number: EAG013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2012
• 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