MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for FLEXI-TIP ROSE 650097-901301 manufactured by Bracco Diagnostics Inc..
| Report Number | 2411512-2019-00005 |
| MDR Report Key | 9129110 |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-11 |
| Date of Event | 2019-01-26 |
| Date Mfgr Received | 2019-09-11 |
| Date Added to Maude | 2019-09-27 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA MARCHILDON |
| Manufacturer Street | 155 PINELAWN ROAD SUITE 230N |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6095142284 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXI-TIP ROSE |
| Generic Name | FLEXI-TIP ROSE |
| Product Code | FGD |
| Date Received | 2019-09-27 |
| Model Number | 650097-901301 |
| Lot Number | 60012452 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO DIAGNOSTICS INC. |
| Manufacturer Address | 155 PINELAWN ROAD SUITE 230N MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-27 |