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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 06/08/2015
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 complaint sample was returned for evaluation was found to have loose/unraveled inner stitching and pdo containment sleeve protruding from the containment sleeve. Based on the as received condition and visual evaluation of the samples, the conditions observed suggest that forces encountered in the deployment of the samples were sufficient to detach 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 pulling the stitching out of the sew holes and displacing the pdo containment sleeve. This report represents one of the two ventralex mesh damaged during implant. Another mdr will be submitted to represent the other mesh associated with the event. 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 that the surgeon was attempting to place the ventralex hernia patch during an open umbilical repair when he noticed what appeared to be a "stitch sticking up" and at this point also noticed the ring was separated from the mesh. This ventralex patch was removed and upon inspection of the second ventralex from the same product case, it also has a separation of the ring from the mesh. Both mesh were put aside and a ventralex st mesh was then used to complete the case with no further issues.

 
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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 Key6750870
MDR Text Key81295695
Report Number1213643-2017-00472
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2018
Device Catalogue Number0010301
Device LOT NumberHUZA0734
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/12/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2015
Was Device Evaluated By Manufacturer? Yes
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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