FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2170496
·
Received July 21, 2011
Report
- Report Number
- 1525712-2011-00361
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- May 31, 2011
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
RMA 859372595 HAS BEEN ISSUED FOR THE RETURN OF THE WHEEL CHAIR.
Description of Event or Problem · 1
THE CONSUMER STATES IT WAS RAINING AND HE ALLEGEDLY GOT STUCK IN THE MUD. WHEN HE WAS TRYING TO GET OUT OF THE MUD HE WAS GOING BACK AND FORTH IN THE CHAIR AND THE HARNESS ALLEGEDLY MELTED. NO INJURY IS ALLEGED.
Description of Event or Problem · 1
THE CONSUMER STATES IT WAS RAINING AND HE ALLEGEDLY GOT STUCK IN THE MUD. WHEN HE WAS TRYING TO GET OUT OF THE MUD, HE WAS GOING BACK AND FORTH IN THE CHAIR AND THE HARNESS ALLEGEDLY MELTED. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | 3GAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 DA |