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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 Separation (1562); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The preparation section of the ifu states "it is recommended that ventralight st mesh be completely immersed in sterile saline for no more than 1-3 seconds immediately prior to placement in order to maximize the flexibility of the prosthesis. " as reported the mesh was not placed in the patient immediately after being hydrated. The mesh was placed down on white paper and covered while the surgeon tended to the patient. This resulted in the st hydrogel coating becoming stuck to the paper as the mesh had been hydrated. Based on the event as reported is a use related issue. 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 the ventralight st was soaked for 3 seconds in normal saline. As reported the patient had bleeding and the surgeon put the mesh on the white paper, covering the mesh. When he took it back, a part of the st hydrogel coating had stuck to the paper and was not on the mesh anymore. The surgeon did not use the mesh and there was no injury to the patient.
 
Manufacturer Narrative
This is an addendum to the initial mdr as the sample was returned and the evaluation has been completed. The returned sample was returned within a paper sleeve and was noted to be stuck to the paper. When pealed back there was resistance felt as it pulled free from the paper. There was residual st coating left on the paper. The st coating was tacky to the touch, which would be expected following hydration. Based on the sample evaluation the results of this report remain unchanged. Placing the hydrated coating side, onto the paper as was reported resulted in the problem experienced. This has been concluded to be a use related issue. 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.
 
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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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5387779
MDR Text Key36756742
Report Number1213643-2016-00018
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue Number5954680
Device Lot NumberHUZG1315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2015
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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