MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-24 for MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) MON-000005 manufactured by Auris Health, Inc..
| Report Number | 3014447948-2020-00005 |
| MDR Report Key | 9875495 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2018-12-06 |
| Date Added to Maude | 2020-03-24 |
| 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 | MR. BENEDICT TOLERO |
| Manufacturer Street | 150 SHORELINE DRIVE |
| Manufacturer City | REDWOOD CITY CA 94065 |
| Manufacturer Country | US |
| Manufacturer Postal | 94065 |
| 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 | 2020-03-24 |
| Catalog 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 CA 94065 US 94065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |