FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3183147
·
Received June 21, 2013
Report
- Report Number
- 9616091-2013-01056
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Report Date
- May 28, 2013
- Manufacturer
- INVAMEX
- Product Code
- IOR
- 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
THE PROVIDER STATED THE FRAME BROKE IN TWO PLACES AT THE WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283372 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | T4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |