FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2990545
·
Received March 5, 2013
Report
- Report Number
- 1531186-2013-00877
- Date Received
- March 5, 2013
- Report Date
- February 6, 2013
- Manufacturer
- KENSTONE METAL
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIST
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES FRONT WHEELS WILL NOT ROLL BEARING SEIZED. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93683 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | KENSTONE METAL | 6895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |