FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 1233886
·
Received November 13, 2008
Report
- Report Number
- 1056601-2008-00027
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- September 15, 2007
- Report Date
- November 10, 2008
- Manufacturer
- HOVEROUND CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. END USER ADVISED THAT SHE MISJUDGED THE DISTANCE OF THE SEATING UPON TRANSFERRING INTO THE MOTORIZED WHEELCHAIR. THE OWNER'S MANUAL WARNS, "THE OPERATION OF THE POWER CHAIR REQUIRES CAUTION AND CONSIDERATION FOR YOUR PERSONAL SAFETY AND THE SAFETY OF OTHERS AROUND YOU".
Description of Event or Problem · 1
END USER ALLEGES WHILE TRANSFERRING INTO THE MOTORIZED WHEELCHAIR, SHE MISJUDGED THE SEATING DISTANCE AND FELL TO THE FLOOR, ALLEGEDLY, FRACTURING HER LEFT LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | ITI | HOVEROUND CORP. | MPV4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |