FDA Adverse Event Injury Summary report: N

DENTAL AMALGAM

MDR report key: 15242814 · Received August 16, 2022

Report

Report Number
MW5111540
Event Type
Injury
Date Received
August 16, 2022
Date of Event
January 1, 1999
Report Date
August 14, 2022
Manufacturer
UNK
Product Code
OIV
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1848244 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848245 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848246 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848247 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848248 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848249 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848250 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848251 DENTAL AMALGAM DENTAL AMALGAM OIV UNK
1848252 DENTAL AMALGAM DENTAL AMALGAM OIV UNK

Patients

Seq Age Sex Outcome Treatment
1 42 YR Female Disability| R ALAWAY| BLOOD GLUCOSE MONITOR| BLOOD SUGAR FORMULA| CALCIUM| CENTRUM SILVER| CEVIMELINE| FISH OIL | FLONASE | GABAPENTIN | LEVOTHYROXINE| OLMESARTAN-HCTZ| OSTEOBIOFLEX EASE | PRAMIPEXOLE| PROPANOLOL | ROSUVASTATIN| ZYRTEC