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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD/BARD SHANNON LIMITED VENTRIOST MESH MESH, SURGICAL, POLYMERIC
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BD/BARD SHANNON LIMITED VENTRIOST MESH MESH, SURGICAL, POLYMERIC Back to Search Results
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).

 
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Brand NameVENTRIOST MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BD/BARD SHANNON LIMITED
MDR Report Key10206115
MDR Text Key197145582
Report NumberMW5095259
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberHUDT2121
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
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