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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 W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955810
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2019
Event Type  Malfunction  
Manufacturer Narrative

The method of hydration was not reported; however, the condition of the mesh in the photos provided is consistent in appearance with mesh that was not properly hydrated prior to insertion. 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. It cannot be determined by photo if the separation resulted in a void in the st coating. Based on the photo review the most probable root cause of the separation is due to the partial hydration of the device. Per the instructions-for-use "the ventralight st mesh w/ echo ps positioning system should be hydrated for no more than 1 -3 seconds just prior to laparoscopic placement. The ventralight st w/ echo ps positioning system must be rolled immediately after hydration. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. To date this is the only reported complaint for this production lot of 195 units released for distribution in august, 2018.

 
Event Description

It was reported that on 10/16/2019 a bard ventralight st w/ echo ps device was being used during a ventral hernia repair procedure. As reported the "case went well but the surgeon had a concern because of alleged delamination of the hydrogel on the mesh. Creating a strange reaction that surgeon wanted to bring back to us. " the mesh was removed from the patient and another one was used to complete the case.

 
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Brand NameVENTRALIGHT ST W/ ECHO
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 Key9324166
MDR Text Key195705108
Report Number1213643-2019-11046
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2020
Device Catalogue Number5955810
Device LOT NumberHUCT1479
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 Received10/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/02/2018
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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