FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4143365
·
Received October 6, 2014
Report
- Report Number
- 9616091-2014-02096
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- September 12, 2014
- Report Date
- September 18, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATED THAT THE FORK ON A (B)(4) WHEELCHAIR SPLIT, WHERE THE WELDED STEM IS. THE END USER WAS BEING PUSHED DOWN THE STREET AND THE FORK COLLAPSED, NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622619 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE REHABILITATION EQUIP | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |