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 2017-05-15 for DENTAL AMALGAM manufactured by Unknown.

Event Text Entries

[75145956] (b)(4). I had 3 amalgam fillings removed/replaced (covered by insurance) when i went in to have a chipped tooth looked at and repaired. There was no safety measures taken to prevent my exposure to the amalgams. No proper drilling technique to reduce the amount of dust and vapor. I had no other noticeable issues at that time, save for anxiety due to finances. I had septocaine numbing shot and nitrous oxide. I was sore for a few days as expected, then ok, then suddenly had facial swelling at five days out. My eyes under were swollen, too. The office refused to see me, because they don't see patients on fridays. My health began to deteriorate. My anxiety went through the roof. I lost 20lbs in under 3 months. My hair became straw like and was falling out. I had a panic attack where i felt a choking sensation which lasted almost 2 weeks. I had heart palpitations, abdominal pains, bowel changes, headaches, insomnia, extreme fatigue. All unusual for me. My gp ran blood work multiple times, i had a ct, mri, x-rays, ultrasounds, ekg. Was told everything was normal. I went to a functional medicine practitioner, and my metabolism barely registered on the screen. Blood work showed hypothyroid, hypoglycemia, adrenal insufficiency, malabsorption, low d, dhea, and insufficient zinc. I spent thousands of dollars in 'covered' tests, and thousands more in trying supplements to regain some stability and healing. We ultimately had to sell our house to pay off debt and have funds available to continue alternative treatments. My children show signs of heavy metal toxicity i believe passed from the amalgams in my mouth. My second born, my son, was on spectrum until intervention. My third has unknown issues currently being explored, and my fourth has mild apraxia and digestive issues, possibly more.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069774
MDR Report Key6566664
Date Received2017-05-15
Date of Report2017-05-12
Date of Event2015-06-01
Date Added to Maude2017-05-15
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 Received2017-05-15
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 2017-05-15

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