MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH; MESH, SURGICAL, POLYMERIC

Catalog Number EAPVPM

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

Date sent to the fda: 08/24/2017.The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a re-occurring umbilical hernia repair procedure on (b)(6) 2017 and the mesh was implanted.During the procedure, while initially implanting and positioning the device, a rip in the mesh side was noticed.The mesh was removed and new device was implanted.No further information is available.

Manufacturer Narrative

Actual sample was returned for evaluation.Visual inspection was performed and partial detachment of the wing from load ring was observed.In addition, the welding of the load ring was damaged in a corner.The partial separation of the wings at the welding area of the load ring may occur during handling.Therefore, the pds components are broken into fragments and a blue suture is visible which fixated the wing with the bottom mesh.As the pvp product is absorbable and was returned opened, during our investigation the sample started to separate into their components, due to degradation process of the mesh had already begun.According to the sample condition, the assignable cause could not be determined.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. .

• Brand Name: PROCEED VENTRAL PATCH
• 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.-CORNELIA; 655 ethicon circle; cornelia 30531
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6816671
• MDR Text Key: 83620774
• Report Number: 2210968-2017-70049
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: EAPVPM
• Device Lot Number: LA8JXXB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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