DENTAL BONDING MATERIAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for DENTAL BONDING MATERIAL manufactured by Unk.

Event Text Entries

[143533008] A dental bonding material applied after braces were removed in 1984 failed. It is a polymer film / ribbon designed to keep tension on teeth instead of a retainer. It failed at the gum line and caused pain and infection. It's self repairing film. It penetrated my face, gums, neck and went through my body. It spread the infection into my face and neck. It spread film material to start the self repairing process. It's a surface mount tension system. It has to tighten to do work. It causes pain throughout the entire body. I had to have all my teeth removed. The film cannot be removed. It stays and tries to repair and put tension on teeth that are no longer there. During the repair process, it uses external forces to pull out film / material needed to repair. Anything that turns or spins, fans, engines, tires, running water, electricity, batteries, a strong breeze, just about any external force pulls it. It sews itself back up. Punches loop holes through the skin for material to stitch itself up. It did this for over a year. One day it stopped. It parked. It started to remove itself. It used the film to protect itself. Covered my entire body in film like a bubble or membrane. It no longer was affected by everything in the environment. It used the film to stimulate a surgery of sorts. The film anchored to my surroundings to hold down my feet, hands, and head. It stimulated hands on my feet. It used the film tension and pressure as a pain killer for inserting what feels like wires into my body. It connects small wires to each polymer strand and connects several of these to a large wire which is used to collapse the strands. The strains have been released, like fired from a gatling gun. The springs from the strands remain and are being pulled out by cheesy robotic arms constantly pulling them. Pair, agony, torture. Four weeks into this removal process so far. Fun stuff. This material is on my mri. It's on a cat scan. Drs say whatever the material is the scars are not made to detect it. It can be seen in my mouth with a 75x microscope. Dentists and oral surgeons don't use a microscope to perform exam. There has been no report. There is nothing they can do. This has taken 2 years of my life. It has cost me a professional career. It has plagued me my whole life. Ribbond came out in 1991. It's safe as it is handed, so it doesn't come apart like it's predecessor. I don't know what is in me. No one will say what the predecessor is. All that i can find is how ribbond is compared to uhmwpe, but no product name or mfr is mentioned. How many people has this disabled. How many have committed suicide. How many committed in mental hospitals. This has been a nightmare. I can only hope this stuff removes itself and i can get my body back. An ftir test would confirm the presence of a polymer left in my mouth. A simple q-tip test, 10 min test. No one will order one. They won't look for it with a microscope either. There has been an absolute refusal to look for any such thing. My general dr and a specialist didn't buy a word of what i said. They know i don't have any drug or mental problems. They ordered tests and scans because they didn't like what they saw. They all came back normal. They never recommended a shrink. They wrote letters to the undiagnosed disease network. I was declined. They said there was nothing they could do. I am on my own going through this. If i wasn't for my wife of 31 years, i don't know what i would do. We are struggling. I hope we make it through this. Fda safety report id# (b)(4)..
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086184
MDR Report Key8551241
Date Received2019-04-24
Date of Report2019-04-20
Date of Event2017-11-21
Date Added to Maude2019-04-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDENTAL BONDING MATERIAL
Generic NameRESIN, DENTURE, RELINING, REPAIRING, REBASING
Product CodeEBI
Date Received2019-04-24
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2019-04-24

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