FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 4048390
·
Received August 29, 2014
Report
- Report Number
- 1531186-2014-03689
- Date Received
- August 29, 2014
- Date of Event
- August 5, 2014
- Report Date
- August 5, 2014
- Manufacturer
- MAXTHAI - MX - E. CHINA DO NOT USE AS OEM
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER THE DEALER, THE RIGHT SIDE HANDLE IS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529494 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | MAXTHAI - MX - E. CHINA DO NOT USE AS OEM | 65650R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |