FDA Adverse Event
Injury
Summary report: N
QUICKIE 2
MDR report key: 3049540
·
Received April 5, 2013
Report
- Report Number
- 2937137-2013-00006
- Event Type
- Injury
- Date Received
- April 5, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 15, 2013
- Manufacturer
- SUNRISE MEDICAL (US) LLC
- Product Code
- IOR
- PMA / PMN Number
- K973673
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL MAKE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFO CAN BE OBTAINED FROM THAT INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
END USER TIPPED OVER IN CHAIR AND HIT HIS HEAD. END USER SUFFERED MINOR CONCUSSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139678 | QUICKIE 2 | WHEELCHAIR, MECHANICAL | IOR | SUNRISE MEDICAL (US) LLC | EIQ2N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |