MAUDE Adverse Event Report: DENTAL AMALGAM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 01/01/1999

Event Type  Injury  

Event Description

Adverse reaction of dental pulp to amalgam in all nine of my teeth with amalgam restorations over a one year period of time in 1999.In that year i had 9 root canals, 2 extractions, two exploratory surgeries, and numerous other procedures to try to get out of pain.Subsequent patch testing which i had done because i was convinced it was an allergic reaction to the metal in the amalgam, revealed 2 positive delayed hypersensitivity reactions to gold, reaction to cobalt, and an irritant reaction to a dental amalgam sample supplied by my employer (dentist - i am a retired (b)(6) ) which was placed on my arm as we ran out of test sites on my back.I wrote an article published online in dentistry iq in august 2001 recounting my full experience.This may be accessed with either the title "what if amalgam is the enemy?" or with my name: (b)(6).I have been invited to write a new article with more current information, and i am awaiting the opportunity to have (b)(6) (memory lymphocyte immunostimulation assay) testing for metals before i submit the article.I am including the medwatch reporting website in the article.My reaction occurred during the period of time when any mention by dental professionals of mercury amalgam fillings being harmful was grounds for possible disciplinary action.So i was told to "prove it", i was told if i had a positive patch test it would have to be reported (it never was reported), i was told to accept my positive reactions to gold as the answer i was looking for and "stop making myself crazy".Testing was done in the department of dermatology, the hospital of (b)(6).Fda safety report id# (b)(4).

• Brand Name: DENTAL AMALGAM
• Type of Device: DENTAL AMALGAM
• MDR Report Key: 15242814
• MDR Text Key: 298248721
• Report Number: MW5111540
• Device Sequence Number: 5
• Product Code: OIV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/14/2022
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2022
• Patient Sequence Number: 1
• Treatment: ALAWAY; BLOOD GLUCOSE MONITOR; BLOOD SUGAR FORMULA; CALCIUM; CENTRUM SILVER; CEVIMELINE; FISH OIL ; FLONASE ; GABAPENTIN ; LEVOTHYROXINE; OLMESARTAN-HCTZ; OSTEOBIOFLEX EASE ; PRAMIPEXOLE; PROPANOLOL ; ROSUVASTATIN; ZYRTEC
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White