FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 4151274
·
Received October 8, 2014
Report
- Report Number
- 1525712-2014-06797
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Report Date
- September 19, 2014
- Manufacturer
- UNKNOWN
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USER ORDERED FROM (B)(6) AND IS MISSING A LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632573 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | UNKNOWN | SELFCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |