FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3020227
·
Received March 25, 2013
Report
- Report Number
- 1531186-2013-01265
- Date Received
- March 25, 2013
- Report Date
- February 27, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. END USER STATES THE BACK LEG EXTENDED OUT AND SHE HAD TO FORCE THE LEG BACK INTO PLACE. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122698 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | UNKNOWN | 91-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |