MAUDE Adverse Event Report: BD/BARD SHANNON LIMITED VENTRIOST MESH MESH, SURGICAL, POLYMERIC

Lot Number HUDT2121

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Constipation (3274)

Event Date 10/31/2019

Event Type  Injury  

Event Description

I had two bi-lateral hernias. I was operated on (b)(6) 2019. Since that day i have had pain in the same area where i can't even walk, sit or move around. The pain comes no matter what i do. I have seen my surgeon/doctor was told the swelling will go down and pain too. It's (b)(6) 2020. And i still suffer from this pain, constipation and swelling in groins area. I have been to the er several times, lab work, x-rays, mri abs nothing can be seen. I feel as if i still had hernia like it was never repaired. Similar symptoms yet no hernia. So it has to be the mesh. I was given the ventrio st mesh that's 11cm x 4cm. I have a copy of all my (b)(6) records. This was done at the (b)(6) hospital in (b)(6). Fda safety report id #: (b)(4).

Event Description

Additional information received from reporter on 10/20/2020 for report number mw5095259: filed a report a few months ago. This is continuation -- i had a bilateral hernia surgery two bard ing ventrio st mesh installed since then i have had pain and discomfort. Still having issues walking and when i move around and pain everyday. Had to go to er 2-3 times no help. Was told by my doctor it was normal, however a year later still pain. I was told to see a pain doctor, spoke to him via phone was told to try physical therapy first, i did via aquatic for other medical issues and i'm still in pain, now waiting to see pain doctor next month a year later. I filed a report a few months ago with you, i did not have serial number and model number for the mesh. I was finally able to get it from va hospital. I have it now. Fda safety report id# (b)(4).

• Brand Name: VENTRIOST MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BD/BARD SHANNON LIMITED
• MDR Report Key: 10206115
• MDR Text Key: 197145582
• Report Number: MW5095259
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2021
• Device Lot Number: HUDT2121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 06/26/2020 Patient Sequence Number: 1