FDA Adverse Event
Other
Summary report: N
POWERED WHEELCHAIR
MDR report key: 1613666
·
Received February 11, 2010
Report
- Report Number
- 1525712-2010-00015
- Event Type
- Other
- Date Received
- February 11, 2010
- Date of Event
- January 24, 2010
- Report Date
- February 11, 2010
- Manufacturer
- INVACARE
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SERIOUS INJURY REPORTED. USER REPORTEDLY REMOVED HIS HAND FROM THE JOYSTICK AND THE CHAIR ALLEGEDLY MOVED ON ITS OWN. IT'S UNCLEAR IF USERS SLEEVE INADVERTENTLY ENGAGED THE JOYSTICK. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME, SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR USER ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THIS ALLEGED INCIDENT. AS A COURTESY THE USERS DEALER IS REPLACING THE COMPONENTS. MDR FILED AS A CONSERVATIVE MEASURE.
Description of Event or Problem · 1
THE CONSUMER ALLEGES HE MOVED AND RAN INTO SOMETHING WHEN HE REMOVED HIS HAND. NO SERIOUS INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE | 3GAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |