MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-13 for MEDTRONIC * manufactured by Medtronic, Inc..
[368351]
Tip of instrument-tuna kit-broke off in pt's bladder causing minimal bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035168 |
| MDR Report Key | 593015 |
| Date Received | 2005-04-13 |
| Date of Report | 2005-04-13 |
| Date of Event | 2005-02-10 |
| Date Added to Maude | 2005-04-21 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC |
| Generic Name | TRANS URETHRAL NEEDLE ABLATION |
| Product Code | MIK |
| Date Received | 2005-04-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 41032V |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 582865 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 710 MEDTRONIC PKWY MINNEAPOLIS MN 554325604 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-13 |