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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950008
Device Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2019
Event Type  malfunction  
Manufacturer Narrative
Based on the event as reported and the sample evaluation, this complaint is confirmed with a use related root cause. As reported the user hydrated the mesh for several minutes prior to placement. Per the instructions-for-use, provided with the device, the "ventralex st hernia patch be completely immersed in sterile saline for 1-3 seconds immediately prior to placement in order to maximize the flexibility of the prosthesis. " to date this is the only reported complaint for this manufacturing lot (b)(4) units released for distribution in july, 2018. A review of the manufacturing records was performed and found that the lot was manufactured to specification.
 
Event Description
It was reported that during an open umbilical hernia repair on (b)(6) 2019 the surgeon attempted to place the ventralex st hernia patch but reported the "gel layer was rubbing off" as she was placing it in the patient. Another mesh was brought in and used successfully without further issue. There was no patient harm. In follow up with the contact it was reported that the mesh patch was hydrated for several minutes prior to placement.
 
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Brand NameVENTRALEX ST
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 Key8397037
MDR Text Key138093398
Report Number1213643-2019-01405
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2020
Device Catalogue Number5950008
Device Lot NumberHUCT1464
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2018
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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