FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3983652
·
Received August 6, 2014
Report
- Report Number
- 1531186-2014-03026
- Date Received
- August 6, 2014
- Date of Event
- July 3, 2014
- Report Date
- July 3, 2014
- Manufacturer
- KENSTONE METAL
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
END USER FRIEND STATES THAT THE 2 FRONT WHEELS WITH SWIVEL, BUT WILL NOT ROLL, CANNOT MANEUVER CHAIR, NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461124 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | KENSTONE METAL | 6895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |