InjuryEJJ
TYTIN
Received Jun 8, 2018 · Event occurred Sep 1, 2015
Report 1815757-2018-00004 · MDR key 7584843
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
NO PATIENT INFORMATION IN REGARDS TO AGE, WEIGHT, ETHNICITY, AND RACE WAS PROVIDED. THE DATE OF EVENT IS ESTIMATED BECAUSE THE EXACT DAY WAS NOT PROVIDED. AN EVALUATION OF THE PRODUCT IS EXPECTED BUT HAS NOT YET BEGUN.
Description of Event or Problem
AN ALLEGED COMPLAINT WAS REPORTED THAT A PATIENT WAS EXPERIENCING PAIN AND THE DOCTOR HAD TO REMOVE THE AMALGAM. IT WAS NOTED THAT TH BOTTOM OF THE AMALGAM LOOKED LIKE "GRAVEL" AS IF IT HAS NEVER SET. THE AMALGAM WAS PLACED (B)(6) 2011 THE PATIENT'S TOOTH HAD TO BE EXTRACTED. NO ADDITIONAL INJURIES OR MEDICAL INTERVENTION WAS NOTED.