FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3953361
·
Received July 23, 2014
Report
- Report Number
- 1525712-2014-03993
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Report Date
- June 18, 2014
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE PROVIDER STATES 3 DIFFERENT INSIGNIA CHAIRS HAVE BROKEN WHERE THE BOLT GOES THROUGH THE BACK CANE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431333 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |