FDA Adverse Event
Injury
Summary report: N
POWER 9000
MDR report key: 308043
·
Received December 5, 2000
Report
- Report Number
- 1525712-2000-00086
- Event Type
- Injury
- Date Received
- December 5, 2000
- Date of Event
- August 2, 2000
- Report Date
- November 7, 2000
- Manufacturer
- INVACARE CORPORATION
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MANUFACTURER RECEIVED A REPORT ALLEGING THAT WHILE THE CONSUMER WAS UNDRESSING, THEIR CLOTHES GOT CAUGHT ON THE BROKEN JOYSTICK AND THE CHAIR RAN OVER THEIR FOOT. AS A RESULT OF THE INCIDENT, THE CONSUMER SUSTAINED A BROKEN FOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWER 9000 | POWERED WHEELCHAIR | ITI | INVACARE CORPORATION | POWER 9000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |