FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3163459
·
Received June 11, 2013
Report
- Report Number
- 9616091-2013-00977
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Report Date
- May 14, 2013
- Manufacturer
- INVAMEX
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATES 2 SPOKES ARE BROKEN ON REAR WHEEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264324 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | ITI | INVAMEX | T4X22RDA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |