FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 4140862
·
Received October 3, 2014
Report
- Report Number
- 9616091-2014-02083
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Report Date
- September 17, 2014
- Manufacturer
- INVAMEX
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE PROVIDER STATES THE SEAT IS CRACKED ALMOST COMPLETELY IN HALF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620334 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | INVAMEX | 9630-4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |