FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4213778
·
Received October 30, 2014
Report
- Report Number
- 9616091-2014-02303
- Event Type
- Malfunction
- Date Received
- October 30, 2014
- Date of Event
- October 10, 2014
- Report Date
- October 10, 2014
- Manufacturer
- INVAMEX
- 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
THERESA STATED TO ROBERT THAT ONE OF THE CYLINDERS SHE HAD ORDERED FOR REPLACEMENT CANNOT BE REPLACED BECAUSE IT WAS SEIZED ON. WE DO NOT KNOW WHAT SIDE WAS NOT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697366 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |