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

Catalog Number PCDG1

Device Problem Material Separation (1562)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

((b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a ventral hernia repair procedure on (b)(6) 2017 and mesh was implanted.Following the procedure, the patient experienced higher than normal pain.An exploratory laparotomy was performed on (b)(6) 2017.The surgeon found that the bowel adhered to the entirety of the mesh.The bowel was pulled which peeled the orc off of the mesh while still being stuck to the bowel.A new like device was placed over the old mesh and tacked down to complete the procedure.It was reported that a large number of tacks were used during each procedure.No device will be returned.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7207240
• MDR Text Key: 97802863
• Report Number: 2210968-2018-70356
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/20/2017

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 Catalogue Number: PCDG1
• Device Lot Number: LGG273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/19/2018
• 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