FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2960040
·
Received February 13, 2013
Report
- Report Number
- 1531186-2013-00591
- Date Received
- February 13, 2013
- Report Date
- February 13, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4) - THE DEALER REPORTED THAT THE 1320RTS RAISED TOILET SEAT ADJUSTABLE KNOBS WERE BROKEN, AND THE ARMS WOULD NOT TIGHTEN ENOUGH TO MAKE THE UNIT STABLE. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63471 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | UNKNOWN | 1302RTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |