FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3843918
·
Received June 2, 2014
Report
- Report Number
- 1531186-2014-02038
- Date Received
- June 2, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 16, 2014
- Manufacturer
- GOODBABY
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
CUSTOMER ALLEGES THE SEAT CRACKED AT THE SEAM IN FRONT OF THE SEAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321151 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | GOODBABY | 96-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 | Other |