FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3830934
·
Received May 23, 2014
Report
- Report Number
- 1525712-2014-02643
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Date of Event
- April 7, 2014
- Report Date
- April 11, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USER ALLEGES CROSSBRACE BROKE AT THE WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307497 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE TAYLOR STREET | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |