FDA Adverse Event
Malfunction
Summary report: N
DEMO 1 MYON FOLDING WHEELCHAIR
MDR report key: 4858546
·
Received June 22, 2015
Report
- Report Number
- 3002416487-2015-00070
- Event Type
- Malfunction
- Date Received
- June 22, 2015
- Report Date
- May 27, 2015
- Manufacturer
- INVACARE CANADA KIRKLAND
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
DEALER STATES THAT THE CUSTOMER ALLEGED THAT THE LEFT SIDE QUICK RELEASE KEEPS COMING OFF BY ITSELF. REPLACING PART NUMBER 1173079 QUICK RELEASE AXLE PLATE KIT UNDER WARRANTY NO PROTOCOL QUESTIONS/NO MORE INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402118 | DEMO 1 MYON FOLDING WHEELCHAIR | WHEELCHAIR, MECHANICAL | IOR | INVACARE CANADA KIRKLAND | MYON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |