FDA Adverse Event
Injury
Summary report: N
QUICKIE Q7
MDR report key: 2823808
·
Received October 29, 2012
Report
- Report Number
- 2937137-2012-00018
- Event Type
- Injury
- Date Received
- October 29, 2012
- Date of Event
- July 11, 2011
- Report Date
- October 15, 2012
- Manufacturer
- SUNRISE MEDICAL (US) LLC
- Product Code
- IOR
- PMA / PMN Number
- K973673
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT IS CURRENTLY BEING HANDLED BY OUR LEGAL DEPARTMENT. WE HAVE INCLUDED ALL THE INFORMATION THAT IS AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THE WHEELCHAIR WILL BE RETURNED FOR INVESTIGATION PURPOSES. IF AND WHEN MORE INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
END USER WAS IN WHEELCHAIR REACHING FOR SOMETHING WHEN THE CHAIR SLIPPED. END USER FELL FROM THE WHEELCHAIR AND BROKE HER LEFT LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKIE Q7 | WHEELCHAIR, MECHANICAL | IOR | SUNRISE MEDICAL (US) LLC | EIR4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |