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 2014-09-20 for DENTAL AMALGAM manufactured by .

Event Text Entries

[16174561] I am disabled with chronic mercury poisoning (confirmed by a porphyrins panel), with no known exposure aside from 12 dental amalgams for 40 years. My 23andme test shows some possible genetic susceptibilities to toxic metals.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038320
MDR Report Key4117327
Date Received2014-09-20
Date of Report2014-09-20
Date Added to Maude2014-09-26
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 Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDENTAL AMALGAM
Generic NameDENTAL AMALGAM
Product CodeEKH
Date Received2014-09-20
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2014-09-20

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