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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950008
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Injury (2348); Disability (2371); Dysuria (2684)
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. The attorney alleges dysuria and will require subsequent medical intervention however,no medical records have been provided. Information is limited at this time. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol ventralex st (device #2). An additional emdr was submitted to represent the bard/davol 3dmax (device #1). Not returned.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2017: the patient underwent repair of a recurrent right inguinal hernia and an umbilical hernia. The patient was implanted with a bard/davol 3dmax mesh (device #1), and a bard/davol ventralex st (device #2). After the patient's hernia mesh surgery, the patient began experiencing constant pain in his right inguinal area and cannot do many physical activities such as bending, stooping, and lifting without increasing the pain. It is alleged that even sitting causes the patient pain in the inguinal area. As alleged, the patient has trouble sleeping sometimes because of the pain. It is alleged that in addition, the patient started having difficulty urinating soon after his hernia mesh surgery. The patient's hernia mesh complications cause the patient pain and suffering and physical impairment. It is alleged that the bard/davol polypropylene surgical mesh is defective. The patient suffered, sustained and incurred, and in reasonable medical probability will continue to suffer, sustain and incur the following injuries and damages, among others: physical pain, mental anguish, disfigurement, phsical impairment, and medical care and treatment.
 
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Brand NameVENTRALEX ST
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
jan ling
100 crossings blvd.
warwick, RI 02886
8015652663
MDR Report Key8006690
MDR Text Key125097396
Report Number1213643-2018-03722
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5950008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
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: 10/25/2018 Patient Sequence Number: 1
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