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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 Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
As reported this was not an out of box failure, the surgeon inadvertently created the hole during the procedure. Attempts were made to obtain additional details regarding the reported event, however the contact was unable to provided any additional information. The sample was discarded by the user facility and is therefore unavailable for evaluation. 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. Device not returned.
 
Event Description
It was reported that during an umbilical hernia repair procedure, using a bard ventralex hernia patch the surgeon inadvertently made a hole in the mesh. The surgeon noticed the hole and the mesh was removed, another was brought in to complete the case. There was no patient injury, however if the surgeon had not noticed the hole and implanted the mesh, having a hole in the mesh may compromise the strength of the repair and has the potential to cause or contribute to 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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6261099
MDR Text Key65216866
Report Number1213643-2017-00029
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 01/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2020
Device Catalogue Number0010301
Device Lot NumberHUAU1681
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2016
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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