MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-05 for STENT * manufactured by Cook Urological.
[124288]
5-6-97 cystoscopy with placement of size 4 french 14 cm stent in left ureter. 10/30/97-during removal, stent broke. Unable to retrieve broken piece of stent. 12/2/97-to or for anesthesia, remaining piece of stent removed under fluoroscopy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 147318 |
| MDR Report Key | 147318 |
| Date Received | 1998-01-05 |
| Date of Report | 1997-12-05 |
| Date of Event | 1997-10-30 |
| Date Facility Aware | 1997-10-30 |
| Report Date | 1997-12-05 |
| Date Added to Maude | 1998-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENT |
| Generic Name | 4 FRENCH 14 CM |
| Product Code | MER |
| Date Received | 1998-01-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | C 265 672 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 143569 |
| Manufacturer | COOK UROLOGICAL |
| Manufacturer Address | 1100 W. MORGAN ST. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 1998-01-05 |