MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-22 for DIAGNODENT CLASSIC 2095 0.574.0500 manufactured by Kavo Dental Gmbh.
[87300517]
As the product was not returned an analysis of the rechargeable battery pack was not possible.
Patient Sequence No: 1, Text Type: N, H10
[87300518]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2017-00060 |
| MDR Report Key | 6885751 |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-24 |
| Device Manufacturer Date | 2015-09-07 |
| Date Added to Maude | 2017-09-22 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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, BW 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIAGNODENT CLASSIC 2095 |
| Generic Name | CARIES DETECTOR |
| Product Code | NBL |
| Date Received | 2017-09-22 |
| Model Number | 2095 |
| Catalog Number | 0.574.0500 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH / RISS, BW 88400 GM 88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |