FDA Adverse Event
Injury
Summary report: N
COMFORTDRIVE 200XDR
MDR report key: 1945487
·
Received November 30, 2010
Report
- Report Number
- 3003637274-2010-00048
- Event Type
- Injury
- Date Received
- November 30, 2010
- Date of Event
- October 28, 2010
- Report Date
- November 3, 2010
- Manufacturer
- KAVO DENTAL GMBH
- Product Code
- DZA
- PMA / PMN Number
- K080677
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PATIENT RECEIVED A VERY SMALL BURN ON CHEEK WHILE DENTIST WAS PERFORMING A STANDARD TREATMENT ON TOOTH #31. NO OINTMENT OR MEDICATION WAS GIVEN TO PATIENT. DURING PRODUCT EVALUATION WAS FOUND THAT THE HEAD HAS A DENT AT 11. THE DENT KEEPS BACK-CAP DEPRESSED CAUSING DRIVE ASSEMBLY TO OVERHEAT DUE TO EXCESSIVE PRESSURE. THE CAUSE FOR OVERHEATING IS THE DENT ON THE HEAD. (B)(4). KAVO DENTAL (B)(4) (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF KAVO DENTAL (B)(4) (THE IMPORTER).
Description of Event or Problem · 1
A PATIENT RECEIVED A BURN ON CHEEK WHILE DENTIST WAS PERFORMING A STANDARD TREATMENT ON TOOTH# 31. NO OINTMENT OR MEDICATION WAS GIVEN TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMFORTDRIVE 200XDR | DENTAL HANDPIECE | DZA | KAVO DENTAL GMBH | 200XDR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |