FDA Adverse Event
Death
Summary report: N
INVACARE THERAPEUTIC SUPPORT SYSTEMS
MDR report key: 936962
·
Received November 2, 2007
Report
- Report Number
- 1525712-2007-00074
- Event Type
- Death
- Date Received
- November 2, 2007
- Date of Event
- October 3, 2007
- Report Date
- October 31, 2007
- Manufacturer
- INVACARE CORP.
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN IN SERVICE FOR 7 YEARS. DEALER STATED THERE IS NO DEFECT OR MALFUNCTION. CONSUMER WAS FOUND FACE DOWN ON THE MATTRESS. MDR FILED BASED ON DEATH.
Description of Event or Problem · 1
CONSUMER WAS ALLEGEDLY FOUND FACE DOWN, DECEASED, ON THE MATTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE THERAPEUTIC SUPPORT SYSTEMS | 890.5170 | FNJ | INVACARE CORP. | BB9572000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |