FDA Adverse Event
Malfunction
Summary report: N
LIKOLIGHT
MDR report key: 1945973
·
Received December 17, 2010
Report
- Report Number
- 8030916-2010-00066
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- January 9, 2009
- Report Date
- February 12, 2010
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.
Description of Event or Problem · 1
THE ATTACHMENT BETWEEN THE BASE AND THE MAST OF THE LIKOLIGHT WAS DAMAGED. THE PT FELL TO THE FLOOR WITH MINOR INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIKOLIGHT | NON-AC POWERED PATIENT LIFT | FSA | LIKO AB | LIKOLIGHT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |