FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3183094
·
Received June 21, 2013
Report
- Report Number
- 1525712-2013-04900
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Report Date
- May 24, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE END USER STATED THE SUCTION CUP STUCK TO THE TUB AND BROKE OFF OF THE CHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283490 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |