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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); Fistula (1862); Pain (1994)
Event Date 01/08/2015
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 the patient's attorney has not provided medical records. Without a lot number a review of the manufacturing records could not be conducted. It is alleged the patient experienced fistula and adhesions. Both fistula and adhesions are listed as possible known adverse reactions in the instructions-for-use. With the currently available information, no conclusion can be drawn. 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) 2006 - patient underwent surgery for repair of an incarcerated umbilical hernia. A ventralex mesh was implanted to repair the hernia defect. On (b)(6) 2015 - patient underwent exploratory laparotomy after presenting to the er 5 days prior with complaints of abdominal pain. Upon examination, the surgeon noted that the outer flange of the ventralex mesh had flipped inward, causing small bowel adhesions and this fistula formation and abdominal wall abscess. The surgeons removed the mesh and consequently approximately 10cm of small bowel, and then performed a resection to repair the damaged area. Patient remained in the hospital for approximately two weeks post op. The attorney alleges the patient experienced pain, adhesions, fistula, abscess, explant and permanent injury.
 
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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 Key6247769
MDR Text Key64712510
Report Number1213643-2017-00024
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 01/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0010302
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 Received12/22/2016
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: 01/12/2017 Patient Sequence Number: 1
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