FDA Adverse Event
Malfunction
Summary report: N
LIKORALL
MDR report key: 1946031
·
Received December 17, 2010
Report
- Report Number
- 8030916-2010-00054
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- November 1, 2009
- Report Date
- December 21, 2009
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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
FACILITY ALLEGES THAT THE PATIENT FELL FROM THE OVERHEAD LIFT. NO INJURY REPORTED AND NO DATE OF ALLEGED INCIDENT IS KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIKORALL | AC POWERED PATIENT LIFT | FSA | LIKO AB | LIKORALL 242S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |