MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for NEPHROSTOMY TUBE UNKNOWN manufactured by Unknown.
[177590131]
Patient presented to the interventional radiology department for right nephrostomy tube malfunction. Tube not inserted at this location and no information related to the date of placement. Tube has been leaking. Patient saw local urologist and referred to interventional radiology. Tube exchanged without complications. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092705 |
| MDR Report Key | 9659264 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-28 |
| Date Added to Maude | 2020-02-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | NEPHROSTOMY TUBE |
| Generic Name | CATHETER, NEPHROSTOMY |
| Product Code | LJE |
| Date Received | 2020-01-31 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |