FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 4091195
·
Received September 16, 2014
Report
- Report Number
- 1531186-2014-04128
- Date Received
- September 16, 2014
- Report Date
- August 22, 2014
- Manufacturer
- KENSTONE METAL
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER DEALER 66550 ROLLATOR WHEELS ARE SPLITTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573746 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | KENSTONE METAL | 66550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |