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 Nausea (1970); Pain (1994); Hypoesthesia (2352)

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.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted multiple loops of bowel that were matted to this old mesh.The old mesh was removed, felt that it would cause some type of fistula or bowel obstruction in the future.It was reported that the patient experienced severe pain, nausea, numbness and shortness of breath.It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.Other procedures are captured in separate file.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 11/05/2020.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.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10743651
• MDR Text Key: 214350846
• Report Number: 2210968-2020-08241
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047761
• UDI-Public: 10705031047761
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: PCDN1
• Device Catalogue Number: PCDN1
• Device Lot Number: GCG074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention