FDA Adverse Event
Malfunction
Summary report: N
DIAGNODENT CLASSIC 2095
MDR report key: 6885751
·
Received September 22, 2017
Report
- Report Number
- 3003637274-2017-00060
- Event Type
- Malfunction
- Date Received
- September 22, 2017
- Date of Event
- August 17, 2017
- Report Date
- September 22, 2017
- Manufacturer
- KAVO DENTAL GMBH
- Product Code
- NBL
- PMA / PMN Number
- K983658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTAL ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
AS THE PRODUCT WAS NOT RETURNED AN ANALYSIS OF THE RECHARGEABLE BATTERY PACK WAS NOT POSSIBLE.
Description of Event or Problem · 1
DESCRIBED IS THAT THE OFFICE MANAGER RECEIVED A SMALL BURN AT HER RIGHT HAND WHEN SHE TOUCHED THE RECHARGEABLE BATTERY PACK OF THE DIAGNODENT. THERE WAS NO MEDICAL CARE NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 668528 | DIAGNODENT CLASSIC 2095 | CARIES DETECTOR | NBL | KAVO DENTAL GMBH | 2095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |