FDA Adverse Event
Other
Summary report: N
PRIDE
MDR report key: 1631491
·
Received March 12, 2010
Report
- Report Number
- 2530130-2010-00020
- Event Type
- Other
- Date Received
- March 12, 2010
- Date of Event
- March 1, 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
NOT A PRODUCT PROBLEM, MDR REPORTED DUE TO INJURY; USER ERROR.
Description of Event or Problem · 1
THE END USER WAS REACHING FOR HER GLASSES AND SHE ALLEGES THAT THE CHAIR MOVED FORWARD CAUSING HER TO FALL OUT. THE USER HIT HER HEAD AND WAS TAKEN TO THE ER.
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 | 70 YR | Required Intervention |