MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-04-07 for RADIOGRAPHIC EQUIPMENT UNK 1100-01-002 manufactured by Fischer Imaging.
[441238]
Traumex buckey cassette tray end stop failed to prevent the tray from exiting the buckey. The tray fell and struck the technologist's foot, resulting in a broken toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418957-2006-00003 |
| MDR Report Key | 697976 |
| Report Source | 07 |
| Date Received | 2006-04-07 |
| Date of Report | 2006-04-07 |
| Date of Event | 2005-12-29 |
| Date Mfgr Received | 2006-03-24 |
| Date Added to Maude | 2006-04-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GARY TURNER, VP |
| Manufacturer Street | 12300 GRANT STREET |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal | 80241 |
| Manufacturer Phone | * |
| Manufacturer G1 | FISCHER IMAGING |
| Manufacturer Street | 12300 GRANT STREET |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80241 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIOGRAPHIC EQUIPMENT |
| Generic Name | DX TRAUMEX |
| Product Code | IYB |
| Date Received | 2006-04-07 |
| Model Number | UNK |
| Catalog Number | 1100-01-002 |
| Lot Number | NA |
| 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 | 687065 |
| Manufacturer | FISCHER IMAGING |
| Manufacturer Address | 12300 GRANT ST. DENVER CO 80241 US |
| Baseline Brand Name | TRAUMEX |
| Baseline Generic Name | RADIOGRAPHIC SYSTEM |
| Baseline Model No | 1100-01-002 |
| Baseline Catalog No | NA |
| Baseline ID | DX TRAUMEX |
| Baseline Device Family | TRAUMEX |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K880530 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-04-07 |