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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955460
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device was returned for evaluation. The sample evaluation confirms sections of the hydrogel coating have stuck together causing voids in the hydrogel material. As reported the mesh was not 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 to stick to the hydrated portion making deployment and placement difficult and causing separation of the hydrogel barrier. The sample evaluation found no manufacturing anomalies. This complaint is confirmed for a use related issue. Review of manufacturing records indicate product was manufactured to specification. No manufacturing anomalies were found. To date, this is the only reported complaint for this manufacturing lot of 189 units released for distribution in june, 2019.

 
Event Description

It was reported that, on (b)(6) 2020, the bard/davol ventralight st w/ echo positioning system was used during a laparoscopic ventral hernia repair procedure. The mesh was not hydrated, and no sutures were applied. The mesh was rolled with the barrier/echo ps¿ positioning system facing in and inserted via a 12 mm trocar. The mesh was tacked using 6 (six) bard/davol optifix clips; when the tacker was being placed, the hydrogel barrier peeled off from the mesh and did not allow the mesh to be in contact with the bowel. There was a delay in procedure, and a new ventralight st mesh was used to complete the procedure. Patient was discharged few hours later and there was no reported patient injury. The surgeon is an experienced user of the device.

 
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Brand NameVENTRALIGHT ST W/ ECHO
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
8005566756
MDR Report Key10955132
MDR Text Key220441122
Report Number1213643-2020-20066
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodePO
PMA/PMN NumberK130968
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 11/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5955460
Device LOT NumberHUDR1355
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/08/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/05/2020 Patient Sequence Number: 1
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