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 Wound Dehiscence (1154); Nausea (1970); Pain (1994); Hernia (2240)

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) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent partial removal surgery and hernia repair surgery on (b)(6) 2008 and mesh was implanted during which the surgeon noted the mesh appeared to have dehisced from the fascia and was therefore resected along with a portion of the hernia sac.It was reported that the patient underwent revision surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2011 during which the surgeon noted three defects which were marsupialized into a single defect.Adhesions of the omentum to the undersurface of the fascia were taken down with cautery.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under separate files.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 08/29/2021.Additional information: a1, a2, b7, d3.Additional b5 narrative: it was reported that the patient experienced recurrent incisional hernia following surgery.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11449917
• MDR Text Key: 238902911
• Report Number: 2210968-2021-02184
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047709
• UDI-Public: 10705031047709
• 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,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCDD1
• Device Catalogue Number: PCDD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR