FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3243415
·
Received July 23, 2013
Report
- Report Number
- 1531186-2013-03315
- Date Received
- July 23, 2013
- Report Date
- July 3, 2013
- Manufacturer
- GENTEEL HOMECARE PRODUCTS
- 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
IT WAS REPORTED THAT A 6291-1 WALKER WOULD NOT LOCK DUE TO A BROKEN RIVET ON THE HANDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343466 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | GENTEEL HOMECARE PRODUCTS | 6291-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |