FDA Adverse Event
Malfunction
Summary report: N
LINEAR III
MDR report key: 384285
·
Received March 19, 2002
Report
- Report Number
- 1423380-2002-00001
- Event Type
- Malfunction
- Date Received
- March 19, 2002
- Date of Event
- December 4, 2001
- Report Date
- March 18, 2002
- Manufacturer
- PROGENY, INC.
- Product Code
- IZW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A TECHNICIAN WAS MANIPULATING THE X-RAY TUBE AND COLLIMATOR WHEN THE COLLIMATOR FELL FROM ITS MOUNTING. THE TECHNICIAN GRABBED THE COLLIMATOR, STRAINING THEIR SHOULDER. THE PATIENT WAS UNHURT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAR III | COLLIMATOR | IZW | PROGENY, INC. | 93741 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |