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

Catalog Number XCPVPS

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being 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.

Event Description

It was reported that the patient underwent umbilical hernia repair on (b)(6) 2017 and mesh was used.When mesh was deployed into defect and pulled up, one of the tags detached from the mesh.Another like device was opened and the surgery proceeded without incident.There was a 5-minute delay to the surgery.There were no adverse patient consequences reported.No additional information has been provided.

Manufacturer Narrative

During investigation the whole pvp started to separate into their components due to initially disintegrated absorbable part of the mesh.This is to be expected when exposing to air humidity over a period of more than 11 weeks (alert date and event date is (b)(6) 2017).The cause of the strap breakage could not be determined.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: 6646397
• MDR Text Key: 77757623
• Report Number: 2210968-2017-60275
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: XCPVPS
• Device Lot Number: KK8DSQB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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