DENTAL AMALGAMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-22 for DENTAL AMALGAMS manufactured by .

Event Text Entries

[948221] Dental amalgam - mercury poisoning - narcolepsy. Excessive daytime sleepiness about 8 mos +/- after having amalgams put in. I could not stay awake, it affected my grades and in college i had to change my degree due to the fact that i could not make the grades due to my excessive daytime sleepiness. For four years i had to live in a intermittent state of sleep, poor quality of life. I was not diagnosed until 2002 with narcolepsy. From that time on i was on provigil, two pills a day until 2007, this improved my quality of life quite a bit, but was not like it was before my fillings. I researched and found that the symptoms of narcolepsy are very similar/the same as that of mercury poisoning. I decided to go into depth to remove the mercury fillings in hopes of curing my narcolepsy, but i wasn't sure it would work. In 2007, i had one of the dental amalgams removed and in the same month,i had the other dental amalgam removed. I have not taken a single provigil since 2007. I have been awake and alert all day without a problem, and i am considering going back to college now that i can think clearly and stay awake! Having the amalgams removed has restored my quality of life. Add'l device explant date: 2008.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5008053
MDR Report Key1132748
Date Received2008-08-22
Date of Report2008-08-09
Date of Event1997-09-01
Date Added to Maude2008-09-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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

Generic NameDENTAL AMALGAMS
Product CodeOIV
Date Received2008-08-22
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key1145877


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-08-22

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