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 2018-01-24 for DENTAL AMALGAM manufactured by Unknown.

Event Text Entries

[98094019] #medwatcher #(b)(4). Severe fatigue, diarrhea and intestinal problems, food intolerance, depressing, anxiety.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074843
MDR Report Key7215612
Date Received2018-01-24
Date of Report2018-01-13
Date of Event2011-03-17
Date Added to Maude2018-01-24
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 CodeEKH
Date Received2018-01-24
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other; 3. Required No Informationntervention 2018-01-24

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