FDA Adverse Event
Injury
Summary report: N
POWERED WHEELCHAIR
MDR report key: 1243779
·
Received November 24, 2008
Report
- Report Number
- 1525712-2008-00120
- Event Type
- Injury
- Date Received
- November 24, 2008
- Date of Event
- March 12, 2008
- Report Date
- November 21, 2008
- Manufacturer
- INVACARE
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER RECEIVED INFORMATION FROM AN INSURANCE CARRIER THAT USERS CHAIR VEERED TO THE LEFT AND WENT OVER A CURB. USER IS REPORTEDLY LEGALLY BLIND. USER ALLEGEDLY WENT TO THE ER, AND HAS RECEIVED SUBSEQUENT TREATMENT WITH A CHIROPRACTOR. INFORMATION ALSO PROVIDED SUGGESTS THE CHAIR WAS SERVICED PRIOR TO THE ALLEGED INCIDENT. MDR FILED BASED ON INJURY.
Description of Event or Problem · 1
WHILE TRAVELING DOWN THE SIDEWALK, THE CHAIR ALLEGEDLY VEERED TO THE LEFT, THE WHEELS LOCKED UP, AND THE CHAIR WENT OVER A CURB. THE CONSUMER ALLEGEDLY LANDED ON HIS WRISTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Required Intervention| S |