FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2396556
·
Received January 4, 2012
Report
- Report Number
- 1525712-2012-00009
- Date Received
- January 4, 2012
- Report Date
- January 4, 2012
- Manufacturer
- HL CORP. (SHENZHEN)
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE FRONT WHEELS ALLEGEDLY JAMMED, CAUSING THE CONSUMER TO FALL. NO INJURY IS ALLEGED. (B)(6) - RETROSPECTIVE REVIEW OF THIS FILE BASED ON PROTOCOL (B)(4) DETERMINED THIS IS AN MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | HL CORP. (SHENZHEN) | 65950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |