MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-26 for MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) MON-000005 manufactured by Auris Health, Inc..
| Report Number | 3014447948-2020-00003 |
| MDR Report Key | 9759170 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2020-02-26 |
| 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 | MRS. ADITI GHIRNIKAR |
| Manufacturer Street | 150 SHORELINE DRIVE |
| Manufacturer City | REDWOOD CITY, CA |
| Manufacturer G1 | AURIS HEALTH, INC. |
| Manufacturer Street | 150 SHORELINE DRIVE |
| Manufacturer City | REDWOOD CITY, CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) |
| Generic Name | BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES |
| Product Code | EOQ |
| Date Received | 2020-02-26 |
| Model Number | MON-000005 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AURIS HEALTH, INC. |
| Manufacturer Address | 150 SHORELINE DRIVE REDWOOD CITY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |