FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3832506
·
Received May 27, 2014
Report
- Report Number
- 1531186-2014-01967
- Date Received
- May 27, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 14, 2014
- Manufacturer
- JUNCHENG
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4) WALKER FRAME BENT AT THE CROSS BRACE CAUSING END USER TO FALL. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311318 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | JUNCHENG | 6240-5F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 MO | Other |