FDA Adverse Event
Malfunction
Summary report: N
INVACARE MATRX FLOVAIR GENTLE CONTOUR 16X18 9153653320
MDR report key: 4340330
·
Received December 18, 2014
Report
- Report Number
- 1219590-2014-00213
- Event Type
- Malfunction
- Date Received
- December 18, 2014
- Report Date
- November 25, 2014
- Manufacturer
- INVACARE CLEVELAND STREET
- Product Code
- IMP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER DEALER THE GEL HAS COMPLETELY EVAPORATED FRO THE COUSHION..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832985 | INVACARE MATRX FLOVAIR GENTLE CONTOUR 16X18 9153653320 | CUSHION, WHEELCHAIR | IMP | INVACARE CLEVELAND STREET | ITFG68 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |