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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954680
Device Problems Material Discolored (1170); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2018
Event Type  Malfunction  
Manufacturer Narrative

The sample was not returned for evaluation. However based on the events as reported the user failed to hydrate the mesh per the instructions-for-use. If the mesh is not hydrated per the instructions-for-use, portions of the hydrogel can become hydrated by bodily fluids during insertion. When this happens the dry portion of the hydrogel barrier will stick to the hydrated portion making deployment and placement difficult and causing separation of the hydrogel barrier. Also reported was that the hydrogel appeared to have changed color. Color variation is a known condition that presents normally in use, and is not function related. The color variation can be more noticeable in laparoscopic procedures due to a combination of factors related to the camera and reflection of the light source within the abdominal cavity. This complaint is confirmed as use related. Per the instructions-for-use: "ventralight st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement. The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating. " 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. Implanted.

 
Event Description

It was reported that on (b)(6) 2018 a davol ventralight st mesh was used during a laparoscopic ventral hernia repair procedure. As reported the surgeon closed the defect, rolled the mesh with the hydrogel (st) inwards (without first hydrating the mesh) and introduced the mesh through the trocar. It is reported that while unrolling the mesh intra-abdominally the mesh stuck to itself. While manipulating the mesh to detach it from itself it was reported that some parts of the hydrogel detached from the mesh. Additional it is reported that the hydrogel appeared to have turned yellow and the mesh became rigid. However, the surgeon chose to implant the mesh, which was fixated with a non-davol mechanical fixation device.

 
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Brand NameVENTRALIGHT ST MESH
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7612912
MDR Text Key111433630
Report Number1213643-2018-02028
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2020
Device Catalogue Number5954680
Device LOT NumberHUCP0326
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/06/2018
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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