FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 4094194
·
Received September 16, 2014
Report
- Report Number
- 1531186-2014-04182
- Date Received
- September 16, 2014
- Report Date
- August 25, 2014
- Manufacturer
- GENTEEL HOMECARE PRODUCTS
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER ALLEGES THE 6300-JRA WALKER HAS A MISSING PIN BY THE RELEASE MECHANISM CAUSING IT TO FREE SPIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573753 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | GENTEEL HOMECARE PRODUCTS | 6300-JRA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |