FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3883940
·
Received June 19, 2014
Report
- Report Number
- 1531186-2014-02165
- Date Received
- June 19, 2014
- Report Date
- May 20, 2014
- Manufacturer
- KENSTONE METAL
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USER STATED THAT THE BRAKES HAVE BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360682 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | KENSTONE METAL | 66550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 MO | Other |