AMALGAM FILLINGS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-14 for AMALGAM FILLINGS manufactured by .

Event Text Entries

[16253348] Forty plus years of amalgam and cracking amalgam that was removed by my dentist led to chronic condition - including severe neck stiffness and inability to turn head to right side, spiking and unpredictable high blood pressure, numbness in feet and toes, arthritis-like soreness and stiffness in right hip, and grover's disease on my chest. This went on for several years until i had my 4 remaining amalgam removed by a holistic dentist, at which point all symptoms improved. At this point, some of my symptoms are gone, some are virtually gone and some are continuing to improve with detoxing actions i continue to take. Dates of use: 40 plus years since 1985 -- 2006. Diagnosis or reason for use: deteriorating health. Event abated after use stopped or dose reduced? Yes, #2. Yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007645
MDR Report Key1076373
Date Received2008-07-14
Date of Report2008-07-14
Date of Event2004-02-01
Date Added to Maude2008-07-23
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

Brand NameAMALGAM FILLINGS
Generic NameAMALGAM FILLINGS
Product CodeOIV
Date Received2008-07-14
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1045488


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2008-07-14

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