FDA Adverse Event
Malfunction
Summary report: N
WHEELCHAIR COMPONENTS
MDR report key: 2993545
·
Received March 7, 2013
Report
- Report Number
- 1525712-2013-01771
- 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
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATED THAT ON THE LEFT REAR SIDE, ONE OF THE PINS AS CAUSED A CRACK TO FORM ON THE BACK. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96860 | WHEELCHAIR COMPONENTS | 890.3920 | KNN | INVACARE TAYLOR STREET | PBD1830 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |