FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3821838
·
Received May 20, 2014
Report
- Report Number
- 1531186-2014-01852
- Date Received
- May 20, 2014
- Report Date
- April 8, 2014
- Manufacturer
- DANYANG MAXTHAI MEDICAL EQUIPMENT
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATED THAT THE BRAKE HANDLE ON A (B)(4) ROLLATOR IS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299655 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | DANYANG MAXTHAI MEDICAL EQUIPMENT | 65650R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |