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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 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. Visual examination finds the device in a damaged condition. The pdo ring within the mesh pocket is partially detached and mesh is damaged (torn). Positioning strap has been removed by user based on the sample evaluation this complaint is confirmed. The noted damage is consistent with a handling related issue. It appears that when attempting to suture the mesh after positioning it in place, the device was inadvertently damaged by the user. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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
Alleged "customer reports the ventralex mesh ( 0010301 ; huzg0681 )" shredded into several pieces "when the doctor began suturing the mesh during an umbilical repair. The surgeon removed the pieces and sutured in another ventralex patch without a problem. " the umbilical case was being performed in an open fashion with sutures only. Surgeon was not using additional force or unusual technique. No patient injury.
 
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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 Key6740128
MDR Text Key80943239
Report Number1213643-2017-00430
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132441
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
Device Expiration Date02/28/2019
Device Catalogue Number0010301
Device Lot NumberHUZG0681
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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