FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 4213551
·
Received October 30, 2014
Report
- Report Number
- 1531186-2014-05222
- Date Received
- October 30, 2014
- Report Date
- October 10, 2014
- Manufacturer
- UNKNOWN
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE END USER STATES THE BRAKES ON THE ROLLATOR ARE GOING BAD. SHE STATES THE BRAKE PAD ON THE LEFT IS GONE AND THE RIGHT IS GOING. NO LOT NUMBER IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694983 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | UNKNOWN | 65650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |