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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number UNKAA077
Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976)
Patient Problems Adhesion(s) (1695); Pain (1994); Disability (2371)
Event Date 08/07/2014
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. Based on the information provided, it is alleged the patient experienced material deformation, folded mesh and adhesions. Adhesions is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. Without the device sample returned for evaluation, the allegation of material deformation and folded mesh can not be assessed at this time. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. 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. Not returned to manufacturer.
 
Event Description
The following was reported to davol by the patient's attorney: (b)(6) 2011 - the patient underwent surgery for repair of ventral incisional hernia, a ventralex hernia patch was implanted to repair the hernia defect. (b)(6) 2014 - the patient underwent an additional surgery when a ct scan revealed the mesh had contracted and folded. (b)(6) 2015 - the patient had to undergo another procedure for repair of the folded mesh and multiple adhesions adherent to the mesh. The attorney alleges the patient has suffered and will continue to suffer physical pain and was severely and permanently injured.
 
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Brand NameVENTRALEX
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7043227
MDR Text Key92467326
Report Number1213643-2017-00891
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/17/2017 Patient Sequence Number: 1
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