MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-02-02 for TOSHIBA XGLA-001A manufactured by Toshiba Medical Co..
[20524645]
Operator was moving the tomography unit when the tube assembly swung down and struck the pt in the head. Operator was evaluated and released by the facility emergency room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020563-2001-00001 |
| MDR Report Key | 315052 |
| Report Source | 07 |
| Date Received | 2001-02-02 |
| Date of Report | 2001-02-02 |
| Date of Event | 2001-01-16 |
| Date Mfgr Received | 2001-01-16 |
| Device Manufacturer Date | 1989-05-01 |
| Date Added to Maude | 2001-02-09 |
| 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 |
| Manufacturer Contact | PAUL BIGGINS |
| Manufacturer Street | 2441 MICHELLE DR |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Manufacturer Phone | 7147305000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSHIBA |
| Generic Name | X-RAY, TOMOGRAPHIC UNIT |
| Product Code | IZF |
| Date Received | 2001-02-02 |
| Model Number | XGLA-001A |
| Catalog Number | XGLA-001A |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 304671 |
| Manufacturer | TOSHIBA MEDICAL CO. |
| Manufacturer Address | 1385 SHIMOISHIGAMI OTAWARA-SHI TOCHIGI JA 324 |
| Baseline Brand Name | TOSHIBA |
| Baseline Generic Name | SYSTEM, X-RAY, TOMOGRAPHIC |
| Baseline Model No | XGLA-001A |
| Baseline Catalog No | XGLA-001A |
| Baseline ID | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K922364 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-02-02 |