MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-30 for COMFORTDRIVE 200XDR 10073570 manufactured by Kavo Dental Gmbh.
| Report Number | 3003637274-2019-00038 |
| MDR Report Key | 9254465 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-10-02 |
| Date Mfgr Received | 2019-10-02 |
| Device Manufacturer Date | 2011-04-29 |
| Date Added to Maude | 2019-10-30 |
| 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, 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 | COMFORTDRIVE 200XDR |
| Generic Name | DENTAL ELECTRICAL HANDPIECE |
| Product Code | EKX |
| Date Received | 2019-10-30 |
| Returned To Mfg | 2019-10-07 |
| Model Number | 200XDR |
| Catalog Number | 10073570 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-10-30 |