FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3781065
·
Received April 30, 2014
Report
- Report Number
- 1531186-2014-01579
- Date Received
- April 30, 2014
- Date of Event
- March 6, 2014
- Report Date
- March 26, 2014
- Manufacturer
- KENSTONE METAL
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATES THE BEARINGS ON FRONT CASTERS CAME APART AND THE END USER WAS NOT INJURED BUT FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259780 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | KENSTONE METAL | 6895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |