FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3954440
·
Received July 24, 2014
Report
- Report Number
- 1531186-2014-02779
- Date Received
- July 24, 2014
- Report Date
- June 18, 2014
- Manufacturer
- JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A WELDMENT TOWARD THE FOOTPLATE HAS COMPLETELY BROKEN OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434436 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD | 6891 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |