FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3212044
·
Received July 8, 2013
Report
- Report Number
- 1525712-2013-05467
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 14, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE SEAT OF THE 9781 SHOWER CHAIR SPLIT IN HALF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312087 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | UNKNOWN | 9781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 | Other |