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

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.

• Brand Name: VENTRALEX ST
• Type of Device: SURGICAL 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 Key: 8006690
• MDR Text Key: 125097396
• Report Number: 1213643-2018-03722
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• 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 Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5950008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability