FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 4173267
·
Received September 26, 2014
Report
- Report Number
- 1056601-2014-00016
- Event Type
- Injury
- Date Received
- September 26, 2014
- Date of Event
- November 25, 2013
- Report Date
- September 24, 2014
- Manufacturer
- HOVEROUND CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION OF THE POWER WHEELCHAIR SUSPECTED. END USER REPORTED ACCIDENTALLY DROVE POWER WHEELCHAIR DOWN STAIRS. HOVEROUND'S OWNER'S MANUAL WARNS END USERS TO REDUCE THE CHANCE OF SERIOUS INJURY OR DEATH FROM TIP-OVER..."NEVER ATTEMPT TO DRIVE A POWER WHEELCHAIR OFF OR UP ONTO A CURB, STAIRS HIGHER THAN 1.5 INCHES, OR AN ESCALATOR."
Description of Event or Problem · 1
END USER'S REPORTS SITTING IN THE POWER WHEELCHAIR OUTSIDE OF HER APARTMENT WHEN SHE ACCIDENTALLY PUSHED THE JOYSTICK IN REVERSE AND DROVE OVER THE EDGE OF THE STAIRCASE, FALLING DOWN 5 STEPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600916 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | ITI | HOVEROUND CORP. | HOVEROUND MPV5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization |