FDA Adverse Event
Other
Summary report: N
KODAK DIRECTVIEW CR CASSETTE
MDR report key: 679414
·
Received February 23, 2006
Report
- Report Number
- 1317307-2006-00003
- Event Type
- Other
- Date Received
- February 23, 2006
- Date of Event
- January 19, 2006
- Report Date
- February 20, 2006
- Manufacturer
- EASTMAN KODAK COMPANY
- Product Code
- MQB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER ALLEGES THEIR CASSETTE HAS AN ARTIFACT THAT LOOKS LIKE NODULAR CANCER AND, BY FLUKE, A PATIENT ENDED UP HAVING A REPEAT CHEST X-RAY 10 DAYS APART WITH THE SAME CASSETTE. SINCE THE REPEATED IMAGE WAS ALSO THE SAME VIEW, THE HOSPITAL WAS PREPARED TO BOOK HER FOR A BIOPSY. A FLUOROSCOPIC EXAMINATION WAS PERFORMED TO VALIDATE THE INITIAL DIAGNOSIS BUT THE RADIOLOGIST COULD NOT FIND THE DENSITY UNDER FLUORO AND THUS DISCOVERED THIS WAS AN ARTIFACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KODAK DIRECTVIEW CR CASSETTE | CR RIGID CASSETTE | MQB | EASTMAN KODAK COMPANY | NA | 1839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |