FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2895726
·
Received January 3, 2013
Report
- Report Number
- 1531186-2013-00023
- Date Received
- January 3, 2013
- Report Date
- January 3, 2013
- Manufacturer
- KENSTONE METAL
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
ON (B)(6) -THE DEALER REPORTED THAT THE 6895 COMMODE SEAT WAS CRACKED. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3221 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | KENSTONE METAL | 6895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |