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

Model Number PCDD1

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

Patient Problems Nausea (1970); Necrosis (1971); Pain (1994)

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) 2009.(b)(4) submitted for adverse event which occurred on (b)(6) 2010.

Event Description

It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent partial omentectomy and partial removal of the previous mesh during which the surgeon noted the entire right side of the previously placed mesh had completely pulled apart from the fascia along almost the entirety of the right fascial border.Multiple omental adhesions had to be taken down form the mesh to obtain surgical exposure.After these adhesions were taken down, a portion of the omentum extremely adherent to the mesh had been dissected away from it.It was reported that the patient underwent partial removal on (b)(6) 2010 during which the surgeon noted the mesh was densely adherent to the small bowel.Portions of old mesh that were not adherent to small bowel were excised with scissors.Approximately 50% of operative time was spent lysing extensive adhesions.Upon closer inspection, a tiny enterotomy without any spillage of succus was found.It was reported that the patient experienced limited to partial and full obstructions of the intestines, small intestine perforations, small intestine injuries, infection, abdominal wall reconstruction, adhesions, chronic inflammation, partial omentectomy, enterotomy, re-anastomosis, necrosis, loss of abdominal wall integrity, severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss.Other procedure is captured under separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 11/8/2021.

Manufacturer Narrative

Date sent to the fda: 12/01/2021.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 08876
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11573107
• MDR Text Key: 259329533
• Report Number: 2210968-2021-02761
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047709
• UDI-Public: 10705031047709
• 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,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2008
• Device Model Number: PCDD1
• Device Catalogue Number: PCDD1
• Device Lot Number: AAG059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2008
• 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