FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2923533
·
Received January 22, 2013
Report
- Report Number
- 1531186-2013-00256
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Report Date
- January 19, 2013
- Manufacturer
- GENTEEL HOMECARE PRODUCTS
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PROVIDER STATES LOWER LEFT SIDE FRAME BROKEN AT WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30265 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | GENTEEL HOMECARE PRODUCTS | 65100 | GT080901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |