FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 7251997
·
Received February 8, 2018
Report
- Report Number
- 2530130-2018-00022
- Event Type
- Injury
- Date Received
- February 8, 2018
- Date of Event
- January 26, 2018
- Report Date
- February 6, 2018
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- UDI-DI
- 00606509100014
- PMA / PMN Number
- K042612
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS WAS NOT A PRODUCT PROBLEM. THIS WAS USER ERROR. FILING DUE TO INJURIES SUSTAINED FROM ALLEGED INCIDENT.
Description of Event or Problem · 1
ALLEGES USER WAS ON A HILL AND GOT STUCK IN MUD. TIRES STARTED SPINNING, SO HE PUT CHAIR IN FREEWHEEL AND IT ROLLED DOWN THE HILL AND CHAIR FLIPPED OVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97448 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | J6 | N/A | 00606509100014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |