FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3013717
·
Received March 20, 2013
Report
- Report Number
- 1531186-2013-01162
- Date Received
- March 20, 2013
- Date of Event
- February 21, 2013
- Report Date
- February 21, 2013
- Manufacturer
- UNKNOWN
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER REPORTED THAT A PLASTIC PIECE ON THE BRAKE WAS BROKEN WHICH COULD CAUSE INSTABILITY TO THE PRODUCT AND CAUSE THE USER TO FALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115159 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | UNKNOWN | 65851B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |