MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-15 for PERCUTANEOUS MALECOT NEPHROSTOMY SET * 082000 manufactured by Cook Urological.
[56992]
Following removal of nephrostomy tube, there was a ringlike foreign body in the renal pelvis which was to be part of the tube. It was removed via flexible urethroscopy 5 days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 86713 |
| MDR Report Key | 86713 |
| Date Received | 1994-08-15 |
| Date of Report | 1994-05-12 |
| Date of Event | 1994-01-22 |
| Date Added to Maude | 1997-04-29 |
| 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 | PERCUTANEOUS MALECOT NEPHROSTOMY SET |
| Generic Name | 14 FR MALECOT CATHETER |
| Product Code | FEW |
| Date Received | 1994-08-15 |
| Model Number | * |
| Catalog Number | 082000 |
| Lot Number | 3042337 |
| ID Number | * |
| Device Expiration Date | 1995-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 85898 |
| Manufacturer | COOK UROLOGICAL |
| Manufacturer Address | PO BOX 227 SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-15 |