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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX SURGICAL MESH Back to Search Results
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.

 
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Brand NameMESH - VENTRALEX
Type of DeviceSURGICAL 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 Key6741421
MDR Text Key80955785
Report Number1213643-2017-00441
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 07/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue Number0010301
Device LOT NumberHUZH0926
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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