FDA Adverse Event
Injury
Summary report: N
QUICKIE
MDR report key: 1062736
·
Received June 17, 2008
Report
- Report Number
- 2937137-2008-00008
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 12, 2008
- Report Date
- June 17, 2008
- Manufacturer
- SUNRISE MEDICAL
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS OF THIS DATE, THIS CHAIR HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION.
Description of Event or Problem · 1
REPORTER STATED THAT THE END-USER CLAIMED THAT THIS PRODUCT IS DEFECTIVE AND THE DEFECT CAUSE HIM TO TIP OVER. THE END-USER STATED THAT THE MOTORS ARE THE DEFECTIVE COMPONENT. THE END-USER IS CLAIMING THAT HE RECEIVED A BROKEN NECK. THERE IS NO STATEMENT WHICH DEPICTS WHAT IS ACTUALLY WRONG WITH THE MOTORS AND NO STATEMENT MENTIONED THAT THE END-USER SOUGHT MEDICAL ATTENTION OR INITIAL OR PROLONGED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKIE | WHEELCHAIR, POWERED | ITI | SUNRISE MEDICAL | QUICKIE S525 | P/N EIS52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |