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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 0010302
Device Problems Defective Device (2588); Folded (2630)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 04/15/2014
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. It is alleged the patient experienced pain, recurrence and adhesions. Adhesions and recurrence are both listed as know possible adverse reactions in the instructions-for-use. Currently with the information provided, it is unclear if the ventralex mesh was removed during the (b)(6) 2014 procedure as it was reported that the patient underwent additional surgery "to repair the hernia defect and remove it. " it is unclear at this time what the "it" is referring to whether it was the previously implant ventralex mesh or the actual hernia itself. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications. 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) 2005 - the patient underwent surgery for repair of an incisional hernia. A ventralex hernia patch was implanted to repair the hernia defect. On (b)(6) 2014 -the patient underwent an additional surgery to repair the hernia defect and remove it. As a result of the ventralex failure, the mesh folded while inside her body causing pain, hernia recurrence, adhesions and scarring. Patient was severely and permanently injured. The attorney alleges the patient experienced pain, hernia recurrence, adhesions, scarring, disability and additional surgical procedure.
 
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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 Key6560079
MDR Text Key74933719
Report Number1213643-2017-00297
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 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2010
Device Catalogue Number0010302
Device Lot Number43HPD478
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 Received04/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2005
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: 05/11/2017 Patient Sequence Number: 1
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