MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX; SURGICAL MESH

Catalog Number 0010301

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol's mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.It was reported to davol, that while performing a hernia repair the surgeon began to place the ventralex mesh with sutures and the mesh "frayed and the suture ring popped out." another ventralex was used to complete the case with no patient harm reported.Visual examination at unaided eye and under magnification was conducted.It was confirmed the ring was removed from the mesh containment sleeve.Further evaluation of the pdo ring shows to be consistent with the ring having been cut to facilitate removal as confirmed by the user.As for why the mesh was frayed and the ring containment sleeve partially detached during the procedure.The root cause was undetermined as there were no manufacturing issues found in the reviewed lot and the complaint sample condition was such (having been cut and altered) that an evaluation conclusion could not be reached.

Event Description

It was reported that while performing a hernia repair the surgeon began to place the ventralex mesh with sutures and the mesh "frayed and the suture ring popped out." another ventralex was used to complete the case.No patient harm reported.

• Brand Name: MESH - VENTRALEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6741421
• MDR Text Key: 80955785
• Report Number: 1213643-2017-00441
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)190228(10)HUZH0926
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 0010301
• Device Lot Number: HUZH0926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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