FDA Adverse Event
Other
Summary report: N
PRIDE
MDR report key: 1220553
·
Received October 29, 2008
Report
- Report Number
- 2530130-2008-00026
- Event Type
- Other
- Date Received
- October 29, 2008
- Date of Event
- June 7, 2008
- Report Date
- October 27, 2008
- Manufacturer
- PRIDE MOBILITY PRODUCTS CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
USER ERROR CAUSED EVENT. NOT A DEVICE PROBLEM. NO DEVICE PROBLEM, NO EVALUATION NECESSARY.
Description of Event or Problem · 1
THE END USER ALLEGES SHE WAS DRIVING UP A VAN RAMP WHEN THE SUN GOT IN HER EYES PREVENTING HER FROM SEEING THE END OF THE RAMP. THIS CAUSED THE END USER TO DRIVE OFF OF THE RAMP WHICH RESULTED IN A FALL. THE END USER SUSTAINED A FRACTURE TO HER COLLARBONE WHICH REQUIRED INITIAL MEDICAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE | POWERCHAIR | ITI | PRIDE MOBILITY PRODUCTS CORP. | 1113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |