FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 2938163
·
Received January 31, 2013
Report
- Report Number
- 2530130-2013-00008
- Event Type
- Injury
- Date Received
- January 31, 2013
- Date of Event
- January 3, 2013
- Report Date
- January 31, 2013
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
CONSUMER STATED THAT THE SEAT WAS ADJUSTED IMPROPERLY DURING HER LAST REPAIR FROM (B)(4) (A DIVIISON OF INVACARE CORPORATION). THE SEAT WAS ADJUSTED TOO HIGH AND THEREFORE THE CONSUMER WAS NOT ABLE TO TRANSFER PROPERLY WHICH CAUSED THE FALL. A PRIDE REPRESENTATIVE VISITED CONSUMER, REPLACED BATTERIES, AND DID AN OVERALL CHECK OF THE DEVICE. THE DEVICE IS WORKING PROPERLY.
Description of Event or Problem · 1
CUSTOMER ALLEGES THAT SHE WENT TO SIT IN THE CHAIR AND FELL AND BROKE HER LEG FROM THE FALL. CONSUMER WENT TO THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42675 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | JAZZY 600XL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |