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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010301
Device Problems Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
Event Date 07/05/2019
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including bowel obstruction, adhesions, abscess and subsequent surgical intervention for mesh explant. The instructions-for-use supplied with the device lists adhesions and infections as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the patch. An unresolved infection may require removal of the device. " should additional information be provided, a supplemental emdr will be submitted.
 
Event Description
Attorney alleges that on or about (b)(6) 2011, the patient underwent surgery for repair of an incisional hernia and a bard/davol ventralex hernia patch was implanted. It is alleged that the patient underwent an additional surgery to remove the ventralex mesh on or about (b)(6) 2019. The surgeon noted that a loop of small bowel was densely adherent to the mesh and the bowel was fused to the mesh in three (3) locations. It is also alleged that as a result, the mesh was "balled" up and required extensive adhesiolysis. Attorney alleges that the patient underwent an additional surgery to repair a small bowel obstruction due to dense adhesions on or about (b)(6) 2019. The surgeon performed a laparotomy and segmental small bowel resection and open lysis of adhesions for greater than three (3) hours. It also alleged that the patient underwent an additional surgery to treat a post-operative wound infection, which included drainage and debridement of an abdominal wall abscess, and removal of additional hernia mesh on or about (b)(6) 2019. It is alleged that the patient was injured severely and permanently. Attorney alleges that the patient has been injured, suffered and will continue to suffer physical pain, disability, impairment and requires further medical treatment, including likely need for future surgeries. It is also alleged that the device was defective.
 
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Brand NameMESH VENTRALEX
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key12445513
MDR Text Key270485102
Report Number1213643-2021-07488
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2016
Device Catalogue Number0010301
Device Lot NumberHUVD0963
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2011
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: 09/09/2021 Patient Sequence Number: 1
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