FDA Adverse Event
Other
Summary report: N
PRIDE
MDR report key: 1613105
·
Received February 12, 2010
Report
- Report Number
- 2530130-2010-00007
- Event Type
- Other
- Date Received
- February 12, 2010
- Date of Event
- December 15, 2009
- Report Date
- February 8, 2010
- Manufacturer
- PRIDE MOBILITY PRODUCTS CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE END USER ALLEGES, SHE WAS ON THE POWERCHAIR WITH POWER ON, WHILE TRAVELING ON A BUS, WHEN A MOTOR CONNECTION STARTED TO SMOKE. THERE WERE NO INJURIES OR PROPERTY DAMAGE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE | POWERCHAIR | ITI | PRIDE MOBILITY PRODUCTS CORP. | Q600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening |