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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 UNKAA077
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Fistula (1862); Neuropathy (1983); Disability (2371)
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. As alleged by the patient's attorney the patient had a fistula; fistulas are a known risk of surgery and are listed as a possible complication in the instructions-for-use. The patient's attorney did not allege any specific device failure and a sample was not returned for further evaluation. No lot number was provided; therefore a review of the manufacturing records is not possible at this time. Based on the limited information provided by the patient's attorney, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device. Should additional information be provided, a supplemental emdr will be submitted. Note: the actual date of removal surgery (device 1)/ implant surgery (device 2) is unknown, therefore we are using (b)(6) 2015 as a date of explant of (device 1) and implant of the ventralex (device 2). This emdr represents the bard/davol ventralex (device 2); an additional emdr will be submitted to represent the bard/davol ventralex (device 1). Note: 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.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2011 - the patient was implanted with bard/davol ventralex mesh (device 1) for the repair of an umbilical hernia. On ni/ni/2015 - the patient underwent removal surgery. Upon entering the abdominal cavity, the patient's surgeon noted that the bard ventralex mesh (device 1) had failed and removed the mesh, during this surgery, the surgeon implanted another bard/davol ventralex mesh (device 2) for a ventral hernia. As reported, the patient has suffered pain, neuropathy, fistula, scarring, and intestinal blockage and will continue to suffer physical pain from her hernia mesh surgery. (devices 1 and 2). The patient's attorney alleges "as a result of having the bard ventralex mesh (devices 1 and 2) implanted, the patient has experienced significant physical pain and suffering, has sustained permanent injury, and has undergone medical treatment and will likely undergo further medical treatment and procedures. ".
 
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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
laura abrams
100 crossings blvd.
warwick, RI 02886
4018258605
MDR Report Key7610411
MDR Text Key111360434
Report Number1213643-2018-02010
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132441
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 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
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 Received06/04/2018
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: 06/18/2018 Patient Sequence Number: 1
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