FDA Adverse Event
Other
Summary report: N
GOLDEN ALANTE GP201R
MDR report key: 1979366
·
Received January 25, 2011
Report
- Report Number
- 2523955-2009-00002
- Event Type
- Other
- Date Received
- January 25, 2011
- Date of Event
- September 9, 2009
- Report Date
- October 14, 2009
- Manufacturer
- GOLDEN TECHNOLOGIES, INC.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
GOLDEN TECHNOLOGIES REPLACED THE DAMAGED WHEELCHAIR ARM AND WARNED THE END USER NOT TO DRIVE THE WHEELCHAIR ON LOOSE GRAVEL AGAIN.
Description of Event or Problem · 1
END USER SAID HE WAS DRIVING DOWN A GRAVEL DRIVEWAY WHEN THE LEFT CASTER WHEEL GOT STUCK IN THE GRAVEL AND TIPPED THE WHEELCHAIR OVER TO THE LEFT. THE END USER EXPERIENCED A NON LIFE THREATENING INJURY TO THE LEFT ARM AND WAS HOSPITALIZED. THE OWNER'S MANUAL SPECIFICALLY WARNS NOT TO DRIVE ON LOOSE GRAVEL. THROUGH USER ERROR, THE PT TRIED TO TRAVERSE THE GRAVEL DRIVEWAY AND TIPPED OVER THE WHEELCHAIR CAUSING THIS ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOLDEN ALANTE GP201R | WHEELCHAIR | ITI | GOLDEN TECHNOLOGIES, INC. | GP201R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |