MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-18 for SERIES 8000 BUCKY UNKNOWN manufactured by Liebel-flarsheim.
[20205079]
It was reporter to ge that the technologist pulled the cassette tray all the way out allowing it to fall and strike his fott. Apparently, this caused a fracture of the toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-1994-00001 |
| MDR Report Key | 16969 |
| Date Received | 1994-03-18 |
| Date of Report | 1994-02-08 |
| Date of Event | 1994-01-17 |
| Date Facility Aware | 1994-01-17 |
| Report Date | 1994-02-08 |
| Date Reported to FDA | 1994-02-09 |
| Date Reported to Mfgr | 1994-02-09 |
| Date Added to Maude | 1994-10-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 | SERIES 8000 BUCKY |
| Generic Name | X0RAY BUCKY |
| Product Code | IXJ |
| Date Received | 1994-03-18 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16902 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH ROAD CINCINNATI OH 452156305 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-18 |