FDA Adverse Event
Other
Summary report: N
SARA 3000
MDR report key: 1981172
·
Received December 8, 2010
Report
- Report Number
- 3004468271-2010-00045
- Event Type
- Other
- Date Received
- December 8, 2010
- Date of Event
- November 8, 2010
- Report Date
- November 8, 2010
- Manufacturer
- MEDIBO MEDICAL PRODUCTS NV
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
FACILITY REPORTED THAT A PATIENT WAS INJURED ON AN ARJOHUNTLEIGH LIFT; NO OTHER DETAILS HAVE BEEN MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SARA 3000 | ACTIVE FLOOR LIFTS | FSA | MEDIBO MEDICAL PRODUCTS NV | HEA0002-US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |