FDA Adverse Event
Other
Summary report: N
SARA 3000
MDR report key: 1943696
·
Received December 15, 2010
Report
- Report Number
- 3004468271-2010-00046
- Event Type
- Other
- Date Received
- December 15, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 15, 2010
- Manufacturer
- MEDIBO MEDICAL PRODUCTS NV
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFO WILL BE PROVIDED PENDING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
WHEN LIFTING, RIGHT FOOT SLIDES OFF FOOT PLATE. RESIDENT IS TALL AND HIS WEIGHT AND FEET ARE PROPORTIONATE. BASED ON RESIDENT SIZE AND LACK OF FOOT CONTROL, RIGHT FOOT SLIPS WHEN RAISING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SARA 3000 | ACTIVE FLOOR LIFT | FSA | MEDIBO MEDICAL PRODUCTS NV | HEA0002-US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |