MAUDE Adverse Event Report: BARD VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM; MESH, SURGICAL, POLYMERIC

Lot Number HUXC1394

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/20/2013

Event Type  Injury  

Event Description

Had hernia repair.They used ventralight st mesh with echo ps positioning system.The mesh was faulty, as i now have another hernia in same place, with constant discomfort.When it rips i get terrible pain.I have been told by dr's that they will not operate on it again until it becomes life threatening.This mesh has caused so much pain and discomfort.

• Brand Name: VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD
• MDR Report Key: 6830758
• MDR Text Key: 84109876
• Report Number: MW5071859
• 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
• Report Date: 08/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2015
• Device Lot Number: HUXC1394
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 49 YR
• Patient Weight: 136