FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3830993
·
Received May 23, 2014
Report
- Report Number
- 1525712-2014-02653
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Date of Event
- March 1, 2014
- Report Date
- April 11, 2014
- Manufacturer
- UNKNOWN
- Product Code
- ILS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USER STATES THE SEAT CRACKED AND HAS PINCHED HIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307835 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | ILS | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 | Other |