MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-12-19 for SAPPHIRE / RAD-60 S/N AT47337 89150 manufactured by Varian X-ray Tube Products.
[173895]
"during a fluoro procedure, the hot oil dripped on pt causing third degree burns. Case was stopped immediately. " description of events as stated by initial report fax to varian x-ray on 12/15/1997.
Patient Sequence No: 1, Text Type: D, B5
[7789037]
Details of fluoro procedure at time of device is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418956-1997-00002 |
| MDR Report Key | 139539 |
| Report Source | 08 |
| Date Received | 1997-12-19 |
| Date of Report | 1997-12-19 |
| Date of Event | 1997-12-09 |
| Date Mfgr Received | 1997-12-15 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1997-12-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAPPHIRE / RAD-60 S/N AT47337 |
| Generic Name | ROTATING MEDICAL X-RAY TUBE |
| Product Code | ITY |
| Date Received | 1997-12-19 |
| Returned To Mfg | 1998-06-01 |
| Model Number | SAPPHIRE |
| Catalog Number | 89150 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136242 |
| Manufacturer | VARIAN X-RAY TUBE PRODUCTS |
| Manufacturer Address | 600 WEST UNIVERSITY DR . ARLINGTON HEIGHTS IL 60004 US |
| Baseline Brand Name | SAPPHIRE/RAD-60 |
| Baseline Generic Name | ROTATING MEDICAL X-RAY TUBE |
| Baseline Model No | SAPPHIRE |
| Baseline Catalog No | 89150 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-19 |