MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-19 for KYPHX EXPRESS * KPE1003 manufactured by Kyphon -medtronic Spine Llc.
[18372737]
Patient was having a kyphoplasty. When the dilating balloon was removed from the spine, there was blood in it. ====================== health professional's impression======================unsure
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1665245 |
| MDR Report Key | 1665245 |
| Date Received | 2010-04-19 |
| Date of Report | 2010-04-19 |
| Date of Event | 2010-01-15 |
| Report Date | 2010-04-19 |
| Date Reported to FDA | 2010-04-19 |
| Date Added to Maude | 2010-04-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | KYPHX EXPRESS |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | OCJ |
| Date Received | 2010-04-19 |
| Returned To Mfg | 2010-01-15 |
| Model Number | * |
| Catalog Number | KPE1003 |
| Lot Number | 01067751 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYPHON -MEDTRONIC SPINE LLC |
| Manufacturer Address | 1221 CROSSMAN AVENUE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-19 |