FDA Adverse Event
Malfunction
Summary report: N
1 RIX-70
MDR report key: 372802
·
Received January 18, 2002
Report
- Report Number
- 8020825-2001-00001
- Event Type
- Malfunction
- Date Received
- January 18, 2002
- Date of Event
- October 15, 2001
- Report Date
- October 16, 2001
- Manufacturer
- TROPHY RADIOLOGIE
- Product Code
- EAP
- Removal / Correction Number
- Z-1099/1101-5
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SUPPORT ARM OF X-RAY BROKE CAUSING UNIT TO FALL. PT HIT ON BACK OF HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1 RIX-70 | DENTAL X-RAY SYSTEM | EAP | TROPHY RADIOLOGIE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |