FDA Adverse Event
Malfunction
Summary report: N
QUICKIE 2 LITE
MDR report key: 2171431
·
Received June 29, 2011
Report
- Report Number
- 2937137-2011-00013
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- April 28, 2011
- Report Date
- June 4, 2011
- Manufacturer
- SUNRISE MEDICAL (US) LLC
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT IS BEING ADDRESSED BY AN ON GOING INVESTIGATION AND ANY NECESSARY MECHANICAL TESTING. AN (B)(4) HAVE BEEN INITIATED. WHEN THE HEALTH HAZARD EVAL IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
AN AUTHORIZED DEALER CALLED IN TO SUNRISE MEDICAL (B)(4) ON (B)(4) 2011 AND STATED THAT THE CASTER HOUSING ASSEMBLY WAS STRIPPED. HE STATED END USER IS (B)(6) POUNDS. NO SERIOUS INJURIES REPORTED FOR THIS COMPLAINT. ON (B)(4) 2011 A SUNRISE MEDICAL (B)(4) INTERNAL FAILURE INVESTIGATOR COMPLETED A PRELIMINARY VISUAL EXAMINATION OF THE CASTER HOUSING AND DETERMINED THAT THIS MAY BE A MALFUNCTION. THREADS HAVE BEEN PULLED OUT OF HOUSING. THERE IS NO KNOWN ROOT CAUSE AT THIS POINT IN THE INVESTIGATION. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKIE 2 LITE | WHEELCHAIR, MECHANICAL / IOR | IOR | SUNRISE MEDICAL (US) LLC | EIQ2N | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |