DENTAL AMALGAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-30 for DENTAL AMALGAM manufactured by Unknown.

Event Text Entries

[63627866] (b)(4). After suffering for years with extreme fatigue and anxiety/panic attacks, shyness and very red itchy hands, i had my amalgam fillings removed without precautions by a dentist who did not believe in mercury toxicity and did not give me an oxygen mask. I breathed in a lot of vapor and dust during the removal of 15 amalgam fillings and shortly after that, i suffered my first migraine headache and have been suffering severe migraines ever since.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5066996
MDR Report Key6215441
Date Received2016-12-30
Date of Report2016-12-22
Date of Event2002-08-02
Date Added to Maude2016-12-30
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 Report3

Device Details

Brand NameDENTAL AMALGAM
Product CodeOIV
Date Received2016-12-30
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2016-12-30

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