FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPR
MDR report key: 2861884
·
Received November 29, 2012
Report
- Report Number
- 3003637274-2012-00057
- Event Type
- Injury
- Date Received
- November 29, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 2, 2012
- Manufacturer
- KAVO DENTAL GMBH
- Product Code
- EFB
- PMA / PMN Number
- K073478
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE ANALYSIS OF THE PRODUCT DID SHOW THAT THE SPRING OF THE BACK UP BUTTON IS MISSING. THIS CAUSED THAT THE BACK CAP BUTTON WAS LOOSE WITHIN IT'S SUPPORT AND AS A RESULT IT RUBBED ON THE INNER PARTS OF THE HEAD WHICH FINALLY CAUSED THE HEAT UP. THE USER INSTRUCTION REQUIRES A FUNCTIONAL AND VISUAL INSPECTION PRIOR TO EACH TREATMENT IN ORDER TO ENSURE THAT THE HANDPIECE IS RUNNING WITHIN SPEC. (B)(4), KAVO DENTAL (B)(4) (THE MFR) IS SUBMITTING THE REPORT ON BEHALF OF (B)(6)(THE IMPORTER).
Description of Event or Problem · 1
DURING A STANDARD DENTAL TREATMENT, THE HANDPIECE HEATED UP AND CAUSED A BURN ON PTS CORNER OF LIP. DENTIST PRESCRIBED A TOPICAL OINTMENT FOR PAIN BUT DOES NOT RECALL THE NAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENTLEPOWER LUX CONTRA ANGLE 25LPR | DENTAL HANDPIECES | EFB | KAVO DENTAL GMBH | 25LPR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |