FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2993493
·
Received March 7, 2013
Report
- Report Number
- 9616091-2013-00388
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Report Date
- February 11, 2013
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER REPORTED THAT THE HOLES IN THE CROSSBRACE FOR THE UPHOLSTERY ARE WALLOWED OUT WHICH COULD CAUSE A STABILITY ISSUE FOR THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97042 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | T4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |