D
Patient 1
THE HEAD OF THE HANDPIECE BECAME HOT AND CREATED A SMALL BURN TO THE BUCCAL MUCOSA CHEEK. PATIENT WAS PRESCRIBED PERIDEX MOUTH RINSE AND HAS COMPLETELY HEALED.
MAUDE MDR 924922
- MDR report key
- 924922
- Report number
- 1419798-2007-00024
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-08-30
- Date received
- 2007-10-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARI LAMBERT, MANAGER
- Address
- 340 EAST MAIN ST. LAKE ZURICH IL 60047
- Phone
- 847-847-8473
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GENTLEPOWER LUX CONTRA ANGLE 25LPA | OPERATIVE DENTAL UNIT ACCESSORY | KAVO AMERICA | EKK | 25LPA | 1002.1526 | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-10-10 | 0 | 1. R |
Event Narratives#
N
Patient 1
MAINTENANCE INFORMATION WAS REVIEWED WITH THE OFFICE AND MAINTENANCE SHEETS WERE SENT. THE WATER SPRAY WAS CLOGGED WITH A PRESENCE OF LOW RESIDUE. THE BACK CAP WAS STUCK IN DUE TO DENTS IN THE HEAD OF THE HANDPIECE.