FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3935756
·
Received July 15, 2014
Report
- Report Number
- 1531186-2014-02539
- Date Received
- July 15, 2014
- Report Date
- June 9, 2014
- Manufacturer
- DANYANG MAXTHAI MEDICAL EQUIPMENT
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES THE RIGHT REAR FRAME BROKE IN HALF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412408 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | DANYANG MAXTHAI MEDICAL EQUIPMENT | 65650R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |