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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN AMALGAM FILLINGS; DENTAL AMALGAM

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UNKNOWN AMALGAM FILLINGS; DENTAL AMALGAM Back to Search Results
Patient Problems Twitching (2172); Dysphasia (2195); Shaking/Tremors (2515)
Event Date 02/16/2014
Event Type  Injury  
Event Description
(b)(6) health put four amalgam fillings in my mouth which is causing side effects the side effects are tremors and eye blinking and speech problems i already had a speech problem and a tic disorder but due to the fact that i have amalgams in my mouth my speech is worse and my tics are worse and i don't remember the date i got my fillings done at (b)(6) health on (b)(6).The date i put down is a estimate date.I only had dental x-rays done at (b)(6) health.(b)(6) health, (b)(6).Reference reports: mw5147510, mw5147511, mw5147512.
 
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Brand Name
AMALGAM FILLINGS
Type of Device
DENTAL AMALGAM
Manufacturer (Section D)
UNKNOWN
MDR Report Key18040191
MDR Text Key327238876
Report NumberMW5147509
Device Sequence Number1
Product Code OIV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/30/2023
Patient Sequence Number1
Treatment
CLONIDINE.; MEDICAL MARIJUANA.
Patient Outcome(s) Required Intervention; Life Threatening;
Patient Age33 YR
Patient SexFemale
Patient Weight103 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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