FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 2873849
·
Received December 14, 2012
Report
- Report Number
- 2530130-2012-00089
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- December 31, 2010
- Report Date
- September 15, 2014
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- K001970
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS INSPECTED AND WAS DETERMINED NOT TO BE THE ISSUE.
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION BY PRIDE. SHOULD THE DEVICE OR FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE SUBMITTED.
Description of Event or Problem · 1
CLAIMANT ALLEGES HE WAS INJURED AS A RESULT OF THE CHAIR MALFUNCTIONING IN TRANSIT. HE FELL OUT OF UNIT CAUSING INJURY.
Description of Event or Problem · 1
CLAIMANT ALLEGES HE WAS INJURED AS A RESULT OF THE CHAIR MALFUNCTIONING IN TRANSIT. HE FELL OUT OF UNIT CAUSING INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | JAZZY SELECT 14 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |