MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-22 for TROPHIE RADIOLOGIE MODEL AD 332 manufactured by Trophie Radiologie, Sa.
[18492368]
Dental technician was injured in 2007, when wall-mounted x-ray machine broke from its arm and fell toward seated dental patient. Technician caught the x-ray machine before it hit the patient; but in doing so injured her arm, shoulders, hands and upper extremity. Technician insured medical expenses and sustained a permanent partial disability. Product was an irix 70 scissor arm x-ray machine manufactured in 1998 by trophy radiologies which was purchased in 2003. Following the incident, shop sent technician's employer a questionnaire with diagrams requesting information about the location of the break - indicating this is not an unknown problem for them and that these machines have a history of breaking because of insufficient strength of the scissor arm. Further research indicates that another countries knew of the problem and issued warnings to dentists in 1995 and 2001 respectively to beware and contact the manufacturer, etc. No fda recall could be presently located.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009652 |
| MDR Report Key | 1293887 |
| Date Received | 2009-01-22 |
| Date of Report | 2009-01-22 |
| Date of Event | 2007-03-05 |
| Date Added to Maude | 2009-02-03 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROPHIE RADIOLOGIE MODEL AD 332 |
| Generic Name | WALL MOUNTED DENTAL X-RAY MACHINE |
| Product Code | EAP |
| Date Received | 2009-01-22 |
| Model Number | AD 332 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TROPHIE RADIOLOGIE, SA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-22 |