FDA Adverse Event
Malfunction
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 2253698
·
Received September 9, 2011
Report
- Report Number
- 3003637274-2011-00050
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 22, 2011
- Manufacturer
- KAVO DENTAL GMBH
- Product Code
- EFA
- PMA / PMN Number
- K073478
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE ANALYSIS OF THE PRODUCT DID SHOW THAT THE HANDPIECE HAD A MEDIUM DEBRIS LEVEL, THE BEARINGS HAVE BEEN GRINDING, WOBBLING AND FALLING APART. THIS CAUSED THE HEAD TO HEAT UP. THE USER INSTRUCTION STATES THAT A HANDPIECE IN SUCH CONDITION MUSTN'T BE USED. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE. (B)(4). KAVO DENTAL (B)(4) (THE MFR) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
DURING A STANDARD TREATMENT WITH A DENTAL ELECTRICAL HANDPIECE A PT RECEIVED A SMALL BURN ON CHEEK. OFFICE APPLIED A UNK TYPE OF OINTMENT BUT NOTHING WAS PRESCRIBED. NO FURTHER MEDICAL CARE WAS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENTLEPOWER LUX CONTRA ANGLE 25LPA | DENTAL HANDPIECE | EFA | KAVO DENTAL GMBH | 25LPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |