DENTURES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-19 for DENTURES manufactured by .

Event Text Entries

[16372595] I have included a full report. I am trying to live on ss and do not have money to waste just to have it sit there. I have spoken to the dean of dental. They have never heard of such a thing. They need to close down then. I purchased dentures from a dr, somewhere around 2004. I reported to him at the time that every time i put the dentures in my mouth my throat would burn and i got so sick at my stomach, he said he would check with his lab and get back with me, he never did, and that was my error for not following up with him. I kept going back to have these teeth adjusted and finally i gave up going because he seemed futile. On approx three months later at six in the morning, i put the denture into my mouth and about twenty minutes later, i passed out and fell to the floor, i don't know how long i laid there, but when i did get up all the bones in the right side of my face were broken, i had to go to the hospital where i stayed for three days, and they never found out what was wrong, nor did i associate this with the dentures, so i did not discuss it with the doctor. I did, however, get my friend to bring my old dentures to the hospital because the new ones were hurting me. January 2008, i went to dental college to have some more dentures made, never dreaming that i would have an even worse reaction. I told them about the allergic reaction i had and was told well, that was probably because it was sitting on a nerve? But that was said by the student doctor. When this denture was made and finished, i wore it for about six hours. I noticed some burning, but nothing major. The teeth needed to be adjusted some more because of the pain they were causing me; when that was done, i noticed that my throat was burning, i was nauseated, and my esophagus was burning all the way down to my stomach and some pain with it. The next time, i went for an adjustment i told the student and the instructor of my problems. They brushed it off as a sore mouth. Anyway, the last time they were adjusted, i wore them six hours and by evening my esophagus was on fire, my stomach was hurting really bad, but the following day was the worst, when i would eat something the food would get to a certain spot just below my breast and it seemed to stay there and pain would shoot everywhere in my chest. This malady stayed for about two or three days after the teeth had been removed from my mouth, and the problem has not arisen again because i have not worn those dentures. Everyone keeps telling me that it cannot be possible because i have been wearing dentures for twenty years or more. I am here to tell you i need new dentures, and i would not go through all of this just to have them sit in a glass. There is something they are using that is poisonous to some people, and i cannot get anyone to believe me. I got old, not stupid. There is something very wrong with these dentures, both sets, and the more they adjust them the more poison is being released into our system. On top of that, i have tried to find an allergist that would treat this kind of thing. Only one i have found in memphis, and he did not take medicare insurance. This needs to be investigated, and people need to listen, there is something in these dentures that was not there twenty years ago, and if they don't believe it, then it is on them. I rest my case. Sincerely, phyllis wilbanks. June 18, 2008. Dates of use early 2004, 2008. Diagnosis or reason for use: no teeth, need new dent. Event abated after use stopped or dose reduced? Yes. Event reappeared after reintroduction yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007364
MDR Report Key1063113
Date Received2008-06-19
Date of Report2008-06-18
Date Added to Maude2008-06-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDENTURES
Generic NameDENTURES
Product CodeNSL
Date Received2008-06-19
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1032311


Patients

Patient NumberTreatmentOutcomeDate
10 2008-06-19

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