TYTIN
Received Jan 7, 2015
Report 1815757-2015-00001 · MDR key 4394061
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Toxicity
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT TWO (2) EMPLOYEES HAD EXPERIENCED HIGH LEVELS OF MERCURY READINGS DUE TO THE HANDLING AND PROCESSING OF USED AMALGAM. THIS IS THE FIRST OF TWO (2) REPORTS.
Additional Manufacturer Narrative
SPECIFIC INFORMATION WITH REGARD TO PATIENT AGE, AND WEIGHT WERE NOT PROVIDED. IT WAS REPORTED THAT THE DOCTOR'S OFFICE AUTOCLAVED CROWNS THAT CONTAINS AMALGAM, SOURCED THE AMALGAM AND SCRAPPED THEM FOR OVER TEN (10) YEARS. THE EMPLOYEE HAD EXPERIENCED A TINGLING SENSATION IN HER HANDS AND FIBROMYALGIA. THE EMPLOYEE SOUGHT MEDICAL ATTENTION WITH A CHELATION THERAPIST AND WAS DIAGNOSED WITH HIGH LEVELS OF MERCURY READING OF 34. THE PATIENT IS CURRENTLY UNDERGOING CHELATION THERAPY. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.