MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-05 for COOK MEDICAL OPEN ENDED URETER CATHETER G14274 020015 manufactured by Cook.
| Report Number | MW5088794 |
| MDR Report Key | 8865568 |
| Date Received | 2019-08-05 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-07-29 |
| Date Added to Maude | 2019-08-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOK MEDICAL OPEN ENDED URETER CATHETER |
| Generic Name | CATHETER, URETERAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2019-08-05 |
| Model Number | G14274 |
| Catalog Number | 020015 |
| Lot Number | 9803796 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-08-05 |