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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 Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

A definitive root cause is undetermined. The sample was received folded with the hydrogel (st) coating facing in and the polypropylene side facing out. There were no signs of contamination. Sutures were placed in the mesh during preparation for use, however, it is unknown if the sutures were placed prior to hydration. The mesh was unfolded noting that the hydrogel (st) coating was sticking but did not separate. The hydrogel (st) coating remained tacky to the touch from being hydrated for use. Evaluation of the sample finds the hydrogel (st) coating to have separated from areas on the mesh as reported. The separation has resulted in a void of the hydrogel barrier. No manufacturing anomalies were found. The mesh was returned hydrated but it is unknown for how long hydration took place. It also was not reported how the mesh was being rolled. It is known that damage to the hydrogel may occur if the mesh is hydrated longer than the recommend 1-3 seconds or rolled with the hydrogel facing out. Based on the information provided a definitive root cause cannot be determined. It possible that the damage inadvertently occurred during subsequent handling and preparation for use when rolling the mesh as reported. However, based on the available information and product evaluation a definitive conclusion cannot be made at this time. 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 when rolling the ventralight st mesh, the customer saw the hydrogel barrier peeling off at two places/spots. The procedure was finished with another mesh. As reported, there was no patient injury.

 
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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 Key9405908
MDR Text Key186532508
Report Number1213643-2019-11681
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2020
Device Catalogue Number5954680
Device LOT NumberHUCU2149
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/22/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/07/2018
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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