FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2898297
·
Received January 7, 2013
Report
- Report Number
- 9616091-2013-00010
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Report Date
- January 4, 2013
- Manufacturer
- INVAMEX
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATED THAT A FORK ON A 12120-37-746 DOLOMITE ROLLATOR HAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7982 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | INVAMEX | 12120-37-746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 | Other |