FDA Adverse Event
Malfunction
Summary report: N
WHEELCHAIR COMPONENTS
MDR report key: 2993527
·
Received March 7, 2013
Report
- Report Number
- 1525712-2013-01766
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Report Date
- February 11, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- KNN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES FOAM IS PULLING AWAY FROM METAL AND PATIENT IS SITTING ON METAL. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97133 | WHEELCHAIR COMPONENTS | 890.3920 | KNN | INVACARE TAYLOR STREET | PBD1820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |