FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4952328
·
Received September 16, 2013
Report
- Report Number
- 9612393-2013-00001
- Event Type
- Malfunction
- Date Received
- September 16, 2013
- Report Date
- September 16, 2013
- Manufacturer
- TAIWAN AN I CO.,LTD.
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER IMPORTER'S MDR: 02/06/2013 - RBS - THE DEALER REPORTED THAT THE IN86AHANFR MECHANICAL WHEELCHAIR CROSSBRACE WAS BROKEN I THE MIDDLE. THERE WAS NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466344 | MECHANICAL (MANUAL) WHEELCHAIR | WHEELCHAIR | IOR | TAIWAN AN I CO.,LTD. | IN86AHANFR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |