InjuryEKQ
THERMAFIL
Received Mar 3, 2006
Report 2320721-2006-00066 · MDR key 682313
Device
Generic name
Gutta Percha Obturator
Manufacturer
Dentsply Tulsa DentalModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Fistula
- Unspecified Infection
Narrative
Description of Event or Problem
AFTER A TOOTH WAS TREATED AND OBTURATED USING THERMAFIL PLUS, IT WAS NOTED THAT INFECTION WAS PRESENT AT THE APEX OF THE TOOTH. ALSO, IT WAS REPROTED THAT A CONTINOUSLY DRAINING FISTULA HAD DEVELOPED. THE PATIENT WAS SUBSEQUENTLY REFERRED TO ANOTHER DOCTOR FOR FURTHER TREATMENT, THOUGH THE DOCTOR HAS REPORTEDLY BEEN UNABLE TO REMOVE THE MATERIAL IN ORDER TO TREAT THE INFECTION. FURTHER INFORMATION WAS REQUESTED, THOUGH NONE IS AVAILABLE AS OF THIS REPORT.