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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 Problems Material Separation (1562); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
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. Sample returned with ring intact within the mesh pocket. The ring itself did not come apart, the mesh material was damaged. 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

Per customer contact: alleged while the surgeon was attempting to suture the ventralex hernia patch the "plastic ring came apart. " there was no patient injury. Another mesh was used to complete the case.

 
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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 Key6740127
MDR Text Key80956129
Report Number1213643-2017-00431
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 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 Date04/28/2019
Device Catalogue Number0010301
Device LOT NumberHUZI1261
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/14/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2015
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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