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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 Problems Material Frayed (1262); Material Separation (1562); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2016
Event Type  malfunction  
Manufacturer Narrative
Based on the available information, we are unable to confirm the reported product problem.It is reported that the sample will be returned for evaluation.When/if the sample is returned and an evaluation has been completed a supplemental mdr will be sent to document our findings.A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies noted.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
The following was reported to davol: it was reported that when the surgeon removed the bard ventralight st hernia patch from the package he noted that the mesh was torn.Another mesh was used without issue, there was no injury to the patient.
 
Manufacturer Narrative
Addendum to document results of the sample evaluation.The sample was visibly contaminated and sutures were left tied to the mesh.No tears or rips were found in the mesh as initially stated by the customer.Further examination of the mesh found a void in the st coating.As the evaluation findings were not consistent with what was initially reported additional follow up was made with the customer.As reported the problem was noted after placement in the body.At this time no definitive conclusion can be made as to why this presented.The ifu supplied with the device 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 (see the table below for recommended trocar size).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.If ventralight¿ st mesh is hydrated longer than 3 seconds and/or does not easily deploy down the trocar, replace trocar and retry with the next available larger sized trocar.A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies noted.
 
Event Description
The following was reported to davol: it was reported that when the surgeon removed the bard ventralight st hernia patch from the package he noted that the mesh was torn.Another mesh was used without issue, there was no injury to the patient.Addendum based on additional information obtained after sample was returned in a contaminated condition: the issue was not an out box problem, it was found after deployment.Per contact."the mesh was rolled in the normal fashion and placed through a trocar.After it was opened the surgeon noticed a yellow color on the mesh which is where he believes the coating was separating." the mesh was removed and another was used to complete the case.
 
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Brand Name
VENTRALIGHT ST MESH
Type of Device
SURGICAL 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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5829417
MDR Text Key50648890
Report Number1213643-2016-00346
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 user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2016
Device Catalogue Number5954680
Device Lot NumberHUYJ0851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2016
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received08/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age28 YR
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