FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3110055
·
Received May 13, 2013
Report
- Report Number
- 3004493922-2013-01041
- Event Type
- Malfunction
- Date Received
- May 13, 2013
- Report Date
- April 16, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE CONSUMER STATED THE RUBBER PART OF THE BACK WHEEL CAME OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210491 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE SUZHOU | TREX28R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 | Other |