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

Catalog Number PVPM

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Received one opened foil and an actual mesh sample in partial blood-soaked condition. 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 could not be determined.

Manufacturer Narrative

(b)(4). 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Additional information indicates ¿the problem (which i have circled in the picture)¿. Is this a picture of the actual device used in the procedure? if yes, please forward the ¿picture¿ / photograph. The lot number kj8pdpb0 is not valid. Please clarify the lot number involved.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and mesh was used. During the procedure, the tab let go of the net and was hanging only in a small piece in the middle. The issue was discovered when the net was in place and the surgeon pulled up the flaps and then noticed that one looked damaged. Another like device was used to complete the procedure. There were no adverse patient consequences reported. Additional information has been requested.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. Additional information was requested and the following was obtained: we do not have the box, but i can see that it is possible that the lot number can be: kj8dpdb0 photo was provided for evaluation. Upon visual inspection of the picture, it was noted that straps folded in were damaged and sample has body fluids. However, no conclusion could be reached as how the sample was damaged due to not returned for analysis. During insertion, be certain to avoid kinking the patch (e. G. , by using clamp or extensive folding/rolling etc. ). Once the mesh patch has been inserted through the defect, manipulate the strap carefully to facilitate proper positioning of the patch. Pulling carefully on the suture loops allows the mesh patch to flatten itself against the abdominal wall.

• 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: 6646624
• MDR Text Key: 105341999
• Report Number: 2210968-2017-60276
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2017

1 Device was Involved in the Event

0 Patients were 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

• Device Expiration Date: 07/31/2018
• Device Catalogue Number: PVPM
• Device Lot Number: KJ8DPDB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial