MAUDE Adverse Event Report: BLADDER MESH; MESH, SURGICAL, POLYMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Fall (1848); Failure of Implant (1924); Unspecified Infection (1930); Dizziness (2194); Fracture, Arm (2351); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 01/01/2020

Event Type  Death  

Event Description

My mother had a bladder mesh implanted inside of her within the last 10 years.(don't have exact date on me), soon after the implant she began getting bladder infection.As the year went by they became more frequent.Getting an infection at least once a month in the past 5 years.In the past 3 years she could get 2 infections, in the last year she would finish a treatment and days later she would get another one.I live in another state than she did and i would be able to feel she was getting one because she would talk nonsense during our conversation we had 4 times a day.She was a part of the class action lawsuit, she wasn't getting rid of the infections possibly around (b)(6) of 2019.She ended up getting dizzy while having an infection.Fell, broke her arm, ended up in a nursing home at first for rehab.But never improved.Losing the ability to walk, and her cognitive abilities diminished.The antibiotics quit working and she ended up falling out of bed because the state of (b)(6) banned the devices, warning staff that she was trying to escape her bed.Another issue i was not happy about.So, to sum it all up, she became antibiotic resistant after many years of infections from the implant of the bladder mesh.My mother died thankfully, peacefully, on (b)(6) 2020.At 10:20 pm in palliative / hospice care, in a hosp in (b)(6).I will help in whatever way i can in providing info to you.I have contacted 2 of the drs my mother frequented for these infections.I hope we all can put a stop to the implantation of these devices so others don't have to needlessly suffer, or die.Fda safety report id# (b)(4).

• Brand Name: BLADDER MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 9693555
• MDR Text Key: 178748359
• Report Number: MW5092882
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other; Disability
• Patient Age: 82 YR
• Patient Weight: 82