FDA Adverse Event
Malfunction
Summary report: N
TSUNAMI AL
MDR report key: 3820241
·
Received February 27, 2014
Report
- Report Number
- 3005905321-2014-00139
- Event Type
- Malfunction
- Date Received
- February 27, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 25, 2014
- Manufacturer
- KI MOBILITY
- Product Code
- IOR
- PMA / PMN Number
- K062660
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
END USER ALLEGES THAT THE BACK SECTION OF THE WHEELCHAIR BROKE CAUSING HIM TO FALL BACKWARDS AND HIT HIS HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122949 | TSUNAMI AL | RIGID WHEELCHAIR | IOR | KI MOBILITY | TSUNAMI AL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |