MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-07 for DIAGNODENT CLASSIC KAVO DIAGNODENT 2095 05740500 manufactured by Kavo Dental Gmbh.
[182409968]
Battery received was send to manufacturer for evaluation. Till now no additional or similar cases are known. Based on current information we consider the issue as a single case. Final report will follow as soon the evaluation are complete.
Patient Sequence No: 1, Text Type: N, H10
[182409969]
During charging process the battery got hot and started melting. Assistant took battery pack out of the office, later than the battery pack started to burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2015-00005 |
| MDR Report Key | 9680461 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2015-03-24 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-03-24 |
| Device Manufacturer Date | 2003-03-04 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KLAUS REISENAUER |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH / RISS, BW 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal | 88400 |
| Manufacturer G1 | KAVO DENTAL GMBH |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH / RISS, 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNODENT CLASSIC |
| Generic Name | CARIES DETECTOR |
| Product Code | NBL |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2015-03-24 |
| Model Number | KAVO DIAGNODENT 2095 |
| Catalog Number | 05740500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH / RISS, 88400 GM 88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |