FDA Adverse Event
Death
Summary report: N
INVACARE THERAPEUTIC SUPPORT SYSTEM
MDR report key: 488576
·
Received October 7, 2003
Report
- Report Number
- 1525712-2003-00114
- Event Type
- Death
- Date Received
- October 7, 2003
- Report Date
- October 7, 2003
- Manufacturer
- DISTRIBUTED PRODUCT
- Product Code
- IKZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
A CONSUMER ALLEGEDLY FELL OUT OF BED WHILE LAYING ON AIR MATTRESS. THIS ALLEGEDLY RESULTED IN THE CONSUMER'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE THERAPEUTIC SUPPORT SYSTEM | 880.5550 | IKZ | DISTRIBUTED PRODUCT | CG8000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Death |