N
Patient 1
UNSET SEALER CAN CAUSE OR CONTRIBUTE TO ACUTE PERIAPICAL INFLAMMATION RESULTING IN PAIN. BECAUSE THIS EVENT REQUIRED INTERVENTION, IT MEETS THE CRITERIA FOR A REPORTABLE EVENT PER 21 CFR PART 803.
MAUDE MDR 5011810
- MDR report key
- 5011810
- Report number
- 8010638-2015-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-07-13
- Date received
- 2015-08-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. HELEN LEWIS
- Address
- 221 W. PHILADELPHIA ST. SUITE 60W YORK PA 17401 US
- Phone
- 717-717-7178
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AH PLUS ROOT CANAL SEALER | RESIN, ROOT CANAL FILLING | DENTSPLY DETREY GMBH | KIF | 60620110 | 1502000678 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-18 | 0 | 1. R |
Event Narratives#
D
Patient 1
IN THIS EVENT IT WAS REPORTED THAT THREE DAYS AFTER TREATMENT WITH AH PLUS, A PATIENT EXPERIENCED PAIN. UPON REOPENING THE ROOT CANAL, THE DENTIST DISCOVERED THAT THE AH PLUS WAS STILL SOFT AND WAS ABLE TO REMOVE THE GUTTA-PERCHA POINT.