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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
The reporter was unable to provided clarification of the report that the mesh "fell apart. " it is reported that the sample is being returned for evaluation; however has not been received to date. At this time no conclusions can be made. If / when the sample is returned and the evaluation has been completed a supplemental mdr will be submitted. 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 while attempting to use a bard ventralex hernia patch it "fell apart. " there was no patient injury and as reported the sample is being returned for evaluation.
 
Manufacturer Narrative
A review of the manufacturing records found that the product passed all required inspections at both end product and subassembly levels. No manufacturing issues associated to the reported event were found in the reviewed lot. To date this is the only reported complaint for this manufacturing lot of 302 units released for distribution on 01/14/2015. As reported the mesh "fell apart" the contact stated that no additional information could be provided. The sample evaluation found that the positioning straps had been cut from the device and the positioning pocket mesh, was torn. Also noted were severe grasper marks on, and stretching of, the eptfe layer. Additionally, it appears that during attempted implantation of the device the user folded the patch in, towards the eptfe layer, not facing out as is instructed in the ifu. The labeling review found that the ifu states to ¿roll the patch parallel to the opening between the straps with the eptfe side facing out for insertion into the defect. The free or unattached end of the positioning strap is left outside of the body during placement. The positioning strap is manipulated to facilitate the proper positioning of the patch. Gently pull up on the positioning strap, which will allow the patch to flatten itself against the underside of the abdominal wall. ¿ the incorrect folding and forces applied during use appears to have led to a combination of factors causing the mesh to tear. This complaint is confirmed for user device interface.
 
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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 Key6389090
MDR Text Key69446662
Report Number1213643-2017-00161
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,Followup
Report Date 03/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
Device Catalogue Number0010301
Device Lot NumberHUYK0675
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2017
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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