FDA Adverse Event
Other
Summary report: N
PRIDE
MDR report key: 1171427
·
Received September 2, 2008
Report
- Report Number
- 2530130-2008-00015
- Event Type
- Other
- Date Received
- September 2, 2008
- Date of Event
- August 23, 2008
- Report Date
- August 27, 2008
- Manufacturer
- PRIDE MOBILITY PRODUCTS CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. PRIDE IS WAITING FOR THE UNIT TO BE RETURNED FROM THE PROVIDER. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. CANNOT DRAW ANY CONCLUSIONS AT THIS TIME.
Description of Event or Problem · 1
THE PATIENT ALLEGES SHE WAS IN HER POWERCHAIR WHEN SHE SAW SPARKS AND FLAMES COMING OUT OF THE PORT OF THE JOYSTICK WHERE THE CABLE PLUGS IN. SHE GOT OUT OF THE POWERCHAIR AND CALLED THE FIRE DEPARTMENT. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE | POWERCHAIR | ITI | PRIDE MOBILITY PRODUCTS CORP. | SELECT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Life Threatening |