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); Inflammation (1932); 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) 2018.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent umbilical hernia repair surgery on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2018 during which the surgeon noted there were small pieces of the posterior mesh that started to dissolved, but were still present.These were all removed.There was a murky brown fluid posterior to the mesh, which was irrigated out.There was an area of omentum that was stuck to the mesh, that was resected using electrocautery.Adhesions were taken down using sharp dissection.It was reported that the patient experienced severe pain, mesh infection, dense adhesions, nausea, inflammation, bulging, stress and anxiety.Other procedure was captured in a separate file.No additional information was provided.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 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: 11092392
• MDR Text Key: 226253241
• Report Number: 2210968-2020-10393
• 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
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 12/29/2020
• 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