FDA Adverse Event
Other
Summary report: N
PRIDE
MDR report key: 1631488
·
Received March 12, 2010
Report
- Report Number
- 2530130-2010-00021
- Event Type
- Other
- Date Received
- March 12, 2010
- Date of Event
- February 24, 2010
- Report Date
- March 8, 2010
- Manufacturer
- PRIDE MOBILITY PRODUCTS CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: NOT A PRODUCT PROBLEM, MDR REPORTED DUE TO INJURY. RESULTS: USER ERROR; PRODUCT USED IN MANNER NOT RECOMMENDED BY MFR.
Description of Event or Problem · 1
THE CUSTOMER WAS SITTING IN THE UNIT WHEN THE BUS COMPANY WAS LIFTING HIM INTO THE BUS. THE END USER ALLEGEDLY FELL FROM THE LIFT WHILE IN THE CHAIR. THE USER WAS GIVEN SHOTS AND AN IV FOR PAIN, AND REQUIRED AN OVERNIGHT HOSP STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE | POWERCHAIR | ITI | PRIDE MOBILITY PRODUCTS CORP. | SELECT GT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization |