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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 5954810
Device Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Based on the event as reported, after hydration the user placed the mesh down on top of the packaging and did not roll the mesh immediately after hydration to protect the hydrogel st coating as prescribed in the instructions-for-use. As such this complaint is confirmed for use related error with no malfunction of the device. To date no other complaints have been reported for this lot of (b)(4) units. As reported the sample is available for return and has not yet been received. However, the sample is not required for root cause determination. Per the instructions-for-use, the "ventralight ¿ st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement. If sutures are being placed, attach the sutures to the ventralight ¿ st mesh before hydration. The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating. ".

 
Event Description

It was reported that a bard ventralight st was being prepared for a robotic ventral hernia repair. As reported the mesh was hydrated and then placed on the mesh packaging. When the operating room tech attempted to remove the mesh from the packaging the hydrogel st coating peeled off the mesh. Another mesh was used to complete the repair. 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 Key8513480
MDR Text Key141904971
Report Number1213643-2019-02965
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 04/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2020
Device Catalogue Number5954810
Device LOT NumberHUCV0548
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/22/2018
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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