MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-17 for ULTRA SAFETY PLUS manufactured by Septodont.
| Report Number | 9610964-2020-00002 |
| MDR Report Key | 9601813 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-17 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-14 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-01-17 |
| 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 Street | 58, RUE DU PONT DE CRETEIL |
| Manufacturer City | SAINT MAUR DES FOSSESS, 94107 |
| Manufacturer Country | FR |
| Manufacturer Postal | 94107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA SAFETY PLUS |
| Generic Name | ULTRA SAFETY PLUS |
| Product Code | DZM |
| Date Received | 2020-01-17 |
| Returned To Mfg | 2020-01-28 |
| Lot Number | F51461AA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEPTODONT |
| Manufacturer Address | 58, RUE DU PONT DE CRETEIL SAINT MAUR, CEDEX VAL-DE-MARNE, 94107 FR 94107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-17 |