MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC

Catalog Number PVPM

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). 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 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 hernia repair on (b)(6) 2017 and the mesh was implanted. During the procedure, the mesh tore. Another like device was used to complete the procedure. There were no adverse patient consequences reported. No further information is available.

Manufacturer Narrative

Returned actual device presented used, blood soaked condition. Both straps were still attached to the device, but one wing was partially detached at the welding with the loading. No further anomalies were detected. The partial separation of the wings at the welding with the load ring may occur during handling and does not have any effect on the product properties and functionality.

• Brand Name: PROCEED VENTRAL PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6375138
• MDR Text Key: 68973959
• Report Number: 2210968-2017-60085
• 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

• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2018
• Device Catalogue Number: PVPM
• Device Lot Number: KH8DWRB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial