MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-07-23 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS G46168 FUS-120045 manufactured by Cook Inc.
| Report Number | 1820334-2019-01759 |
| MDR Report Key | 8816235 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-07-23 |
| Date of Report | 2019-07-23 |
| Date of Event | 2019-07-08 |
| Date Mfgr Received | 2019-07-08 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2019-07-23 |
| 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. LARRY POOL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | EZN DILATOR, CATHETER, URETERAL |
| Product Code | EZN |
| Date Received | 2019-07-23 |
| Model Number | G46168 |
| Catalog Number | FUS-120045 |
| Lot Number | 9447677 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-23 |