UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-25 for UNKNOWN manufactured by Unk.

Event Text Entries

[890523] Since receiving 'silver" amalgam fillings around age 10, i have had many problems that come and go, exacerbated by stress. The problem is the mercury in my dental fillings causing toxic sign. Lab reports did not show mercury toxicity because i was never tested for it by drs. They just maybe didn't know to test for it. All blood work i have had done cover the years has been within normal limits. But i would show the following signs after my 3 dental fillings were placed around age 10: decreased energy level, had just enough energy to go to school then slept a lot, face got red as a beet with exercise, hands and feet very cold, md as a child told me i had 'low blood" but iron pills did not help, low basal temp of 95 degrees, hypersensitive, hermit-like stayed alone with no desire to socialize much, wanted to argue, sometimes took an act of god for me to control feelings of rage, timid, fearful, avoiding confrontations, lack of self-confidence, diminished ability to smell. At age 27 during stressful divorce, i was hospitalized 3 times in a 2 month period for psychosis-- "schizophreniform" fancy for dr doesn't know why i'm psychotic but needs a diagnosis for payment. Was unable to be strong and work things out with my husband, got a divorce, moved back in with my parent for 2 1/2 yrs, got better myself taking myself off the anti-psychotic drugs. I had difficulty getting pregnant and took me 6 mos of deliberate trying to conceive a child. Have had irregular periods since beginning menses. Due to being hypersensitive and not handle stress well and getting upset easily, i have had about 20 jobs in my 16 yrs as an rn. I have been unable to hold down a full-time jobe for more than 10 mos d/t i get physically worn out or stressed out and either quit or change to part-time. I have had nearly unbearable rounds of depression, intense crying spells, thoughts of suicide, and small things going wrong have been big to me. I have had trouble forgiving others, intense rage at my mother for how she treated me as a child and would dwell on those negative thoughts and just couldn't seem to get past them. Blurry vision since high school, poor hearing now and quite forgetful now, too. For the past two yrs have developed signs of neurological disease: fine intentional tremors of my hands and my knee "giving" out when i walked like you see people with multiple sclerosis do. I have been apathetic, withdrawn, have lost interest in life. A medical intuitive told me i had "sluggish liver". I recently did a liver flush and got out 1 3/4 cups of gall stones and crystals. I have spent entire years' salary on nutritional supplements, special diets, psychotherapy, alternative medicine to relieve me of my signs of depression and difficulty with interpersonal relationships, none helped. Scripts for anti-depressants from my nurse practitioner and drs did not help. As a psychiatric nurse, i tried all samples of anti-depressants for free -- none helped. I have not been working at all since 11/07 d/t fear of rejoining work force, lack of self-confidence, indecision, no interest in things. Learned about mercury in dental fillings, got mine replaced one week later. Saw immediate improvement that very night -- no longer get angry. Woke up the next morning for the first time in many, many yrs with loving thoughts toward my mom. I understand she was just sick in the past and just let it be. I no longer ruminate about that at all. I called her up, nice talk and we are kindly emailing each other. I now am more understanding of others, no need to be so impulsice and angry. Energy level comes and goes, but at least it's improvements. And i feel my brain is clearer. Note that my mother had manu silver fillings inher mouth when i was a child & she was an irritable person. She has had those removed 2 years ago. I've had receding gums since around age 10. Metallic taste in my mouth, and very badbreath unrelieved by brushing. My liver cleanses helped the breath. Just prior to amalgam removal, the gums around the amalgams were gently throbbing at times. "silver" dental amalgam, put in by my dentist in 1978. I had them in my mouth for about 30 yrs, till two weeks ago when they were replaced with ceramic fillings. #2 dose or amount: 3 fillings in upper molars. Dates of use: had in my mouth 30 yrs. #4 diagnosis or reason for use: cavity filling. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007437
MDR Report Key1066033
Date Received2008-06-25
Date of Report2008-06-25
Date of Event2008-06-06
Date Added to Maude2008-07-07
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameDENTAL AMALGAM FILLING
Product CodeOIV
Date Received2008-06-25
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key1035874
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2008-06-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.