MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-19 for BOWL GUIDEWIRE GW2000CT HD-395-GW2000CT manufactured by Deroyal (hopspital Disposable).
| Report Number | 3014527682-2019-00003 |
| MDR Report Key | 8808269 |
| Date Received | 2019-07-19 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-06-11 |
| Date Facility Aware | 2019-07-02 |
| Date Mfgr Received | 2019-07-02 |
| Date Added to Maude | 2019-07-19 |
| 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 | MRS. CHEYENNE STEWART |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC MO 65738 |
| Manufacturer Country | US |
| Manufacturer Postal | 65738 |
| Manufacturer Phone | 4177303937 |
| Manufacturer G1 | RESOURCE OPTIMIZATION AND INNOVATION |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC MO 65738 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65738 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BOWL GUIDEWIRE |
| Generic Name | BOWN G-WIRE N/S |
| Product Code | KMK |
| Date Received | 2019-07-19 |
| Model Number | GW2000CT |
| Catalog Number | HD-395-GW2000CT |
| Lot Number | 49449941 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL (HOPSPITAL DISPOSABLE) |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-19 |