MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-27 for ORALBPWRPWRORALCARERFLSSENSIULTRATHINEB60 manufactured by Braun Gmbh Werk Marktheidenfeld.
| Report Number | 3000302531-2020-00038 |
| MDR Report Key | 9763687 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON-MONTGOMERY RD |
| Manufacturer City | MASON, OH |
| Manufacturer Country | US |
| Manufacturer G1 | BRAUN GMBH WERK MARKTHEIDENFELD |
| Manufacturer Street | 40 BAUMHOFSTRASSE |
| Manufacturer City | MARKTHEIDENFELD, D-97828 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-97828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORALBPWRPWRORALCARERFLSSENSIULTRATHINEB60 |
| Generic Name | TOOTHBRUSH, POWERED |
| Product Code | JEQ |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-11 |
| Model Number | EB60 |
| Lot Number | P9281 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAUN GMBH WERK MARKTHEIDENFELD |
| Manufacturer Address | 40 BAUMHOFSTRASSE MARKTHEIDENFELD, D-97828 GM D-97828 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |