FDA Adverse Event
Injury
Summary report: N
POWERED WHEELCHAIR
MDR report key: 1901360
·
Received November 10, 2010
Report
- Report Number
- 1525712-2010-00167
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 10, 2010
- 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 A SUMMONS THAT USER FELL ASLEEP AND INADVERTENTLY ENGAGED THEIR JOYSTICK, DROVE INTO A TOOL BOX, AND ALLEGEDLY BROKE A TOOTH ALONG WITH AN UNSPECIFIED HEAD INJURY. NATURE OF COMPLAINT SUGGESTS A USER ERROR. MDR FILED BASED ON ALLEGED SERIOUS INJURY.
Description of Event or Problem · 1
THE CONSUMER IS PRONE TO FALLING ASLEEP IN HIS WHEELCHAIR AND AS A RESULT, HE ALLEGEDLY ENGAGED THE JOYSTICK ACCIDENTALLY, CAUSING HIM TO RUN INTO A METAL TOOL CHEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE | M41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |