FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3133439
·
Received May 29, 2013
Report
- Report Number
- 1531186-2013-02349
- Date Received
- May 29, 2013
- Report Date
- December 5, 2012
- Manufacturer
- UNKNOWN
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
INVACARE AWARENESS DATE (B)(4) 2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013. PER DEALER, THE SEAT IS CRACKED.
Description of Event or Problem · 1
THE DEALER IS REPORTING THAT THE SEAT CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234317 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | UNKNOWN | 96-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |