MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-19 for * MAX 100 X-RAY TUBE UNK manufactured by Ge Medical Systems.
[221944]
Pt incurred 1st degree burns on right side of body (face, arm, chest) as well as a question of eye exposure from splattered hot oil from x-ray machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 327950 |
| MDR Report Key | 327950 |
| Date Received | 2001-04-19 |
| Date of Report | 2001-04-16 |
| Date of Event | 2001-04-10 |
| Date Facility Aware | 2001-04-10 |
| Report Date | 2001-04-16 |
| Date Reported to FDA | 2001-04-16 |
| Date Reported to Mfgr | 2001-04-16 |
| Date Added to Maude | 2001-04-24 |
| 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 |
| 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 | * |
| Generic Name | X-RAY TUBE |
| Product Code | ITY |
| Date Received | 2001-04-19 |
| Model Number | MAX 100 X-RAY TUBE |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | MST MODEL 625 X-RAY GENERATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 317343 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Manufacturer Address | PO BOX 414 MILWAUKEE WI 53201 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-19 |