FDA Adverse Event
Injury
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 1243780
·
Received November 24, 2008
Report
- Report Number
- 1525712-2008-00128
- Event Type
- Injury
- Date Received
- November 24, 2008
- Date of Event
- September 24, 2008
- Report Date
- November 21, 2008
- Manufacturer
- KENTSTONE
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DISTRIBUTED PRODUCT. AS A CONSERVATIVE MEASURE MDR FILED BASED ON SERIOUS INJURY.
Description of Event or Problem · 1
THE CONSUMER STATES SHE SAT DOWN ON THE ROLLATOR AND THE ROLLATOR ALLEGEDLY UNLOCKED, PUSHING HER INTO A WALL AND DUMPING HER FORWARD. HER LEGS ALLEGEDLY GOT ENTWINED WITH THE ALUMINUM LEGS OF THE ROLLATOR, CAUSING BRUISES ON HER LEGS AND HAS SEEN A DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | KENTSTONE | 1034BL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |