MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-03 for TROPHY-FU47 FU-47 * manufactured by Trophy.
[207823]
This is the failure of the new design which was supposed to fix the old design failure of radiographic head and arm breaking off and crashing down on a supine pt and/or operator trophy's previous voluntary recall was supposed to address this problem. This unit was newly modified by trophy. The problem is not fixed and is dangerous.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022559 |
| MDR Report Key | 345663 |
| Date Received | 2001-08-03 |
| Date of Report | 2001-08-03 |
| Date of Event | 2001-08-01 |
| Date Added to Maude | 2001-08-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROPHY-FU47 |
| Generic Name | X-RAY UNIT |
| Product Code | FAP |
| Date Received | 2001-08-03 |
| Returned To Mfg | 2001-08-02 |
| Model Number | FU-47 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 334996 |
| Manufacturer | TROPHY |
| Manufacturer Address | 106 RUE DE LA JARRY VINCENNES FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-08-03 |