FDA Adverse Event
Other
Summary report: N
ANGENIEUX
MDR report key: 362539
·
Received November 20, 2001
Report
- Report Number
- 3019090-2001-00005
- Event Type
- Other
- Date Received
- November 20, 2001
- Date of Event
- November 5, 2001
- Manufacturer
- ALM
- Product Code
- FSY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE O.R. TECHNICIAN WAS ADJUSTING THE POSITION OF THE LIGHT WHEN THE EVENT OCCURRED. THE LIGHT HEAD FELL OUT OF IT'S MOUNT IN THE ARM, HIT THE TECHNICIAN ON THE HEAD AND LEFT SHOULDER; AND CAUSED THE TECHNICIAN TO FALL TO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52653 | ANGENIEUX | SURGICAL LIGHT | FSY | ALM | AX-10 DUEL FREE MOTION ARM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |