D
Patient 1
WHEN APPLYING THE ETCHANT TO THE PT'S TOOTH, THE END OF THE CARTRIGDE DETACHED RESULTING IN THE CONTENTS OF THE CARTRIDGE BEING EXTRUDED INTO THE PT'S MOUTH.
MAUDE MDR 316236
- MDR report key
- 316236
- Report number
- 2424472-2001-00001
- Event key
- 0
- Event type
- 3
- Date received
- 2001-02-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- WILLIAM FREY, JR.
- Address
- 570 W. COLLEGE AVE P.O. BOX 872 YORK PA 17405 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 | DELTON PIT & FISSURE SEALANT | DENTAL SEALANT | DENTSPLY PROFESSIONAL DIVISION | EMN | NA | 279415 | 000204 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-02-13 | 0 | 1. O |