FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3725455
·
Received April 3, 2014
Report
- Report Number
- 1525712-2014-01616
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Report Date
- March 5, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE IS BROKEN WELD WHERE THE TUBE ATTACHES TO THE PIVOT BRACKET ON THE POWER WHEELCHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201630 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE TAYLOR STREET | TDXSIV-HD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |