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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 Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/19/2018
Event Type  malfunction  
Manufacturer Narrative
As reported the surgeon did not hydrate the mesh prior to insertion. Per the instructions-for-use the mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement. The sample was returned in a contaminated state. The sample is noted to have a small section of hydrogel separated from the mesh, consistent with the hydrogel sticking and peeling away from the mesh. While attempting to place the non-hydrated device it is possible that fluid came in contact with areas of the hydrogel. Inherently, if a dry area of the hydrogel should come in contact with a hydrated area; the dry area will pull moisture from the hydrated area causing the two sides to stick together. An attempt to separate the two sides could result in the hydrogel peeling off of one side of the mesh and sticking to the other side. Based on the information provided and the sample evaluation this complaint is confirmed for use related. The ifu states, 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. A minimum sized trocar is recommended for the laparoscopic delivery of ventralight ¿ st mesh. Insert the prosthesis through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not over force the prosthesis through trocar. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december, 2017. 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 report that on (b)(6) 2018 a robotic assisted laparoscopic incisional hernia repair was being performed with a bard/davol ventralight st mesh. As reported the mesh was inserted into the patient's abdomen without hydration. After insertion the mesh folded together and as the surgeon attempted to open it back up (within the abd), the sepra portion (hydrogel) of the mesh stuck together and peeled off of the polypropylene mesh. The surgeon reported removing the mesh from the patient's abdomen and used a bard/davol ventralight st w/ echo ps to complete the case without further issue. As reported, there was no patient injury or harm.
 
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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 Key7265995
MDR Text Key100259823
Report Number1213643-2018-00251
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
Device Catalogue Number5954450
Device Lot NumberHUBW0142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2017
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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