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

Catalog Number 0010302

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2015

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.The ventralex mesh was found to have loose/undone inner stitching and the recoil ring protruding from the containment sleeve.Based on the as received condition of the sample and evaluation performed by fa and aqe, the condition of the sample suggests that forces encountered in the deployment of the sample were sufficient to break the monofilament, the root cause is concluded to be user/device interface related.The complaint sample appears to have been manipulated in an abnormal manner resulting in the displacing/pulling the stitching out of the sew holes.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported to the sales rep, by the facility, that during placement into the patient, the ventralex patch came apart at the ring.Case was completed using another mesh.There was no patient injury.

• 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: 6726422
• MDR Text Key: 80580849
• Report Number: 1213643-2017-00415
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 0010302
• Device Lot Number: HUYE0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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