MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for COOK MEDICAL manufactured by Cook Medical Inc..
[24234311]
Catheter would not straighten out. Unable to put through ureter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055749 |
| MDR Report Key | 5032631 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-08-06 |
| Date Added to Maude | 2015-08-26 |
| 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 |
| Generic Name | 5FR URETERAL ILLUMINATION CATHETER |
| Product Code | FCS |
| Date Received | 2015-08-12 |
| Lot Number | 5868469 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL INC. |
| Manufacturer Address | BLOOMINGTON IN 47402 US 47402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |