AMALGAM FILLINGS - HG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-30 for AMALGAM FILLINGS - HG manufactured by Unk.

Event Text Entries

[882518] In 2005, experienced severe fatigue -would need to stop and rest several times just going from house to car, etc. - at which time i consulted dr. I asked to be tested for hg and was ordered blood tests. Results of tests were normal, even when i asked specifically about my mercury levels, dr suggested i was depressed -which i felt i was not- and prescribed wellbutrin. Helped slightly with fatigue until lack of sleep made me punchy. Went for second opinion. Asked again specifically for hg. Results came back, but was told hg was not tested. Searched internet, found info on dmps and testing for hg not by blood. Found local dr. To test urine. On two months later, removed all hg fillings. Next day had energy to walk 2 miles back for appt to remove incomplete old root canal and one more filling. Reclaimed energy from second day till present today, did not need naps from then on except from staying up late using my new found energy. Aches, stiffness, and digestive problems subsided after about 1-2 months. Dose or amount: amalgam hg vapor release. Frequency: daily. Route: po. Dates of use: 1967-2005. Diagnosis or reason for use: tooth restoration. Event abated after use stopped or dose reduced? : yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5007475
• MDR Report Key: 1067779
• Date Received: 2008-06-30
• Date of Report: 2008-06-30
• Date of Event: 2005-09-01
• Date Added to Maude: 2008-07-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMALGAM FILLINGS - HG
• Generic Name: AMALGAM FILLING
• Product Code: OIV
• Date Received: 2008-06-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 1036371
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention; 3. Deathisabilit	2008-06-30