FDA Adverse Event
Other
Summary report: N
BRILLIANCE BIG BORE
MDR report key: 1403317
·
Received June 10, 2009
Report
- Report Number
- 1525965-2009-00030
- Event Type
- Other
- Date Received
- June 10, 2009
- Date of Event
- April 28, 2009
- Report Date
- June 4, 2009
- Manufacturer
- PHILIPS HEALTCARE
- Product Code
- JAK
- PMA / PMN Number
- K033357
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PATIENT'S GOWN SNAGGED ON A CT GANTRY AND WAS PULLED IN AN UPWARD MOTION. NO DEATH OR INJURY HAS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE BIG BORE | JAK - CT SCANNER | JAK | PHILIPS HEALTCARE | 728243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |