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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 5954460
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2017
Event Type  Malfunction  
Manufacturer Narrative

The sample is confirmed for separation of the hydrogel barrier. As reported the mesh was hydrated for two seconds before being placed through a 12mm trocar into the abdomen. There were no manufacturing anomalies noted on the returned sample and a review of the manufacturing records found the lot was manufactured to specification. Based on the information provided, the investigation performed and the sample evaluation, no definitive conclusion can be made as to why there was a separation of the hydrogel barrier. As the hydrogel separation was not reported as an out of box failure, it is possible that parts of the hydrogel barrier were not completely hydrated. Inherently, if dry hydrogel should come in contact with a hydrated area; the dry hydrogel will pull moisture from the hydrated area causing the two sides to stick together. The ifu states the mesh should, ¿be completely immersed in sterile saline for no more than 1-3 seconds immediately prior to placement in order to maximize the flexibility of the prosthesis. The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating. " 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 during a case the bard ventralight st hernia patch was hydrated for 2 seconds and placed through a 12mm trocar. After placement in the abdomen a separation of the hydrogel barrier was noted and the patch was removed from the site without issue and another was used to complete the case. There was no injury to the patient.

 
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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 Key6743626
MDR Text Key81142061
Report Number1213643-2017-00454
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 07/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2018
Device Catalogue Number5954460
Device LOT NumberHUAX2387
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/12/2016
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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