FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 2930228
·
Received January 25, 2013
Report
- Report Number
- 2530130-2013-00007
- Event Type
- Injury
- Date Received
- January 25, 2013
- Date of Event
- January 21, 2013
- Report Date
- December 5, 2013
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- K042612
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVALUATION BY PRIDE AT THIS TIME. SHOULD THE DEVICE OR FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE SUBMITTED.
Additional Manufacturer Narrative · 1
A PRIDE PROVIDER REPLACED THE STIRRUPS (STRAP, TOE/ANKLE) ON THE POWERCHAIR. THE DEVICE IS WORKING PROPERLY.
Description of Event or Problem · 1
CUSTOMER ALLEGES HE GETS HIS FOOT CAUGHT BETWEEN THE FRONT WHEEL AND FOOTPLATE WHILE DRIVING UNIT BECAUSE HIS FOOT SLIPS OFF.
Description of Event or Problem · 1
CUSTOMER ALLEGES HE GETS HIS FOOT CAUGHT BETWEEN THE FRONT WHEEL AND FOOTPLATE WHILE DRIVING UNIT BECAUSE HIS FOOT SLIPS OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36057 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | JAZZY 614 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |