FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2990732
·
Received March 5, 2013
Report
- Report Number
- 1531186-2013-00907
- Date Received
- March 5, 2013
- Report Date
- February 7, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4) IT WAS REPORTED BY THE CONSUMER THAT THE 6895 COMMODE SEAT CRACKED DURING USE. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93400 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | UNKNOWN | 6895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |