FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3260162
·
Received August 1, 2013
Report
- Report Number
- 9616091-2013-01410
- Event Type
- Malfunction
- Date Received
- August 1, 2013
- Report Date
- July 18, 2013
- Manufacturer
- INVAMEX
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE SNAP BUTTON ON THE 6291-HDA WALKER HAS BROKEN OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360586 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | INVAMEX | 6291-HDA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |