MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2001-12-05 for SAPPHIRE 150TH / RAD 21 SAPPHIRE 150TH/RAD 21 54-21204-LF manufactured by Varian Medical Systems, X-ray Products.
[16263449]
Pt underwent a uteroscopy for microhematuria. During procedure hot oil leaked on pt's arm and stomach. The pt sustained third degree burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717855-2001-00001 |
| MDR Report Key | 364299 |
| Report Source | 06,08 |
| Date Received | 2001-12-05 |
| Date of Report | 2001-11-26 |
| Date of Event | 2001-09-25 |
| Date Mfgr Received | 2001-09-25 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 2001-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | ALAN STRINGHAM |
| Manufacturer Street | 1678 SOUTH PIONEER RD |
| Manufacturer City | SALT LAKE CITY UT 84104 |
| Manufacturer Country | US |
| Manufacturer Postal | 84104 |
| Manufacturer Phone | 8019735000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAPPHIRE 150TH / RAD 21 |
| Generic Name | X-RAY TUBE HOUSING ASSEMBLY |
| Product Code | ITY |
| Date Received | 2001-12-05 |
| Model Number | SAPPHIRE 150TH/RAD 21 |
| Catalog Number | 54-21204-LF |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 353406 |
| Manufacturer | VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS |
| Manufacturer Address | 1678 SOUTH PIONEER RD. SALT LAKE CITY UT 841044296 US |
| Baseline Brand Name | SAPPHIRE 150TH/RAD 21 |
| Baseline Generic Name | X-RAY TUBE HOUSING ASSEMBLY |
| Baseline Model No | SAPPHIRE 150TH/ |
| Baseline Catalog No | 54-21204-LF |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-12-05 |