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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 W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955460
Device Problems Crack (1135); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2018
Event Type  malfunction  
Manufacturer Narrative
The sample evaluation confirms as was reported that the mesh had not been hydrated. The evaluation shows evidence that the mesh was rolled with the hydrogel barrier facing out. The instructions-for-use prescribe that the user,"hydrate the device for no more than 1¿3 seconds just prior to rolling. " and to, "roll the device tightly on itself starting at the edge parallel to the bard® logo and continue across with the polypropylene side on the outside and bioresorbable (hydrogel) coated side with the echo ps¿ positioning system on the inside. " visual examination confirms cracks noted in the hydrogel barrier. This condition can present if the material is not hydrated as recommended. This complaint is confirmed for use related as the damage to the hydrogel barrier was due to the mesh being rolled not hydrated with the barrier facing out. 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 on (b)(6) 2018 a bdi surgery / davol ventralight st w/ echo device was being used during a robotic laparoscopic ventral hernia repair. As reported the mesh was noted to be "splitting" after being inserted into the patient. In follow up with the contact it was reported that the mesh was not hydrated prior to being rolled for insertion and was rolled with the sepra barrier (hydrogel) facing in. It was after the mesh was placed into the abdomen the surgeon noticed the "sepra barrier was coming off. " the mesh was removed and another was used to complete the case without further issue.
 
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Brand NameVENTRALIGHT ST W/ ECHO
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 Key7395147
MDR Text Key104415641
Report Number1213643-2018-00882
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130968
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 04/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2018
Device Catalogue Number5955460
Device Lot NumberHUAY1799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2017
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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