FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 4090261
·
Received September 15, 2014
Report
- Report Number
- 2530130-2014-00070
- Event Type
- Injury
- Date Received
- September 15, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 15, 2014
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- K042612
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS CLAIM IS NOT PRODUT RELATED. REPORTED BASED UPON INJURY. USER ERROR WAS THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
CUSTOMER WAS DRIVING TO HER RESTROOM AND DROVE INTO HER TOILET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568379 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | Q6 EDGE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization |