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 2020-02-27 for GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE 0570-0374 0570-0375 manufactured by Verathon Medical Ulc.
| Report Number | 9615393-2020-00035 |
| MDR Report Key | 9763362 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. COREY KASBOHM |
| Manufacturer Street | 20001 N CREEK PKWY |
| Manufacturer City | BOTHELL, WA |
| Manufacturer Country | US |
| Manufacturer Phone | 6295760 |
| Manufacturer G1 | VERATHON MEDICAL ULC |
| Manufacturer Street | 2227 DOUGLAS ROAD |
| Manufacturer City | BURNABY, BRITISH COLUMBIA V5C 5A9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5C 5A9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE |
| Generic Name | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
| Product Code | EOQ |
| Date Received | 2020-02-27 |
| Model Number | 0570-0374 |
| Catalog Number | 0570-0375 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL ULC |
| Manufacturer Address | 2227 DOUGLAS ROAD BURNABY, BRITISH COLUMBIA V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |