MAUDE Adverse Event Report: C.R. BARD INC BARD 3D MAX LIGHT HERNIA MESH; MESH, SURGICAL PLOYMERIC

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Dysuria (2684)

Event Date 10/27/2017

Event Type  malfunction  

Event Description

Had an ethicon ultrapro hernia mesh put in on (b)(6) 2015 mesh failed, had severe pain and problems urinating and discomfort problems walking due to the pain.Had 2nd surgery done same doctor repaired mesh (b)(6) 2017.Now i am having the same painful problems and may need a 3rd surgery.Are there others having the same issue? afraid to have the same mesh again the 3rd time! what should i do? have doctors, hospital records from 1st surgery sent for records from 2nd surgery.

Event Description

Add'l info received from reporter on (b)(6) 2018 for mw5077143: had 1st surgery, an ethicon ultrapro mesh put in on (b)(6) 2015; it failed, made report to fda then had bard 3d light mesh put in on (b)(6) 2017 that also failed making this report for the bard 3d light mesh that also has failed.Are others having same problem with the bard mesh.I need another surgery and do not want it put in if there is a problem.Thanks (b)(6).Ref # mw5077320.

• Brand Name: BARD 3D MAX LIGHT HERNIA MESH
• Type of Device: MESH, SURGICAL PLOYMERIC
• Manufacturer (Section D): C.R. BARD INC
• MDR Report Key: 7506298
• MDR Text Key: 108150766
• Report Number: MW5077143
• Device Sequence Number: 0
• Product Code: FTL
• 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: 06/11/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 95