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

Catalog Number PVPS

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The product upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2017 date and the mesh was implanted.During the procedure, the straps ripped while suturing.Another like device was used to complete the procedure.No further information is available.

Manufacturer Narrative

One opened foil and an actual mesh sample of product code pvps, lot # la8jkbb0 in partial blood-soaked condition were received for analysis.During visual inspection of the used sample, body fluids on the implant and partial detachment of the wing from load ring was observed at the device.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 has already begun.According to the sample condition, the assignable cause of performance - straps tear off device, could not be determined.

• 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.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6900589
• MDR Text Key: 87641749
• Report Number: 2210968-2017-70373
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061533
• 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,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: PVPS
• Device Lot Number: LA8JKBB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 11/10/2017
• 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