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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 5954450
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/31/2020
Event Type  Malfunction  
Manufacturer Narrative

At this time, no conclusion can be made. While the sample evaluation is anticipated it has not get begun. To date this is the only reported complaint for this manufacturing lot. Review of the manufacturing records is in process. When the investigation has been completed, a supplemental emdr will be submitted.

 
Event Description

As reported, while performing a laparoscopic incisional hernia repair procedure, it was discovered that the adhesive coating was peeling off the ventralight st mesh. There was a minimal delay and the procedure was completed using another device. There was no reported 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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10075479
MDR Text Key193038765
Report Number1213643-2020-04942
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,Followup
Report Date 06/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2020
Device Catalogue Number5954450
Device LOT NumberHUCP2569
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/09/2018
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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