FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 1030163
·
Received April 16, 2008
Report
- Report Number
- 1056601-2008-00006
- Event Type
- Injury
- Date Received
- April 16, 2008
- Date of Event
- December 7, 2007
- Report Date
- March 26, 2008
- Manufacturer
- HOVEROUND CORPORATION
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. THE TRANSIT AUTHORITY'S SECURITY VIDEO REVEALED THE END USER SLUMPED OVER THE RIGHT ARMREST AND OPERATING THE MOTORIZED WHEELCHAIR ERRATICALLY.
Description of Event or Problem · 1
END USER ALLEGES WHILE OPERATING THE MOTORIZED WHEELCHAIR, THE UNIT WENT OFF A SUBWAY PLATFORM AND ONTO THE TRACKS. ALLEGEDLY, AS A RESULT OF THE INCIDENT END USER FRACTURED HIS LEFT ELBOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | ITI | HOVEROUND CORPORATION | MPV5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |