FDA Adverse Event
Death
Summary report: N
*
MDR report key: 308133
·
Received December 7, 2000
Report
- Report Number
- 1525712-2000-00090
- Event Type
- Death
- Date Received
- December 7, 2000
- Date of Event
- October 30, 2000
- Report Date
- November 17, 2000
- Manufacturer
- INVACARE CORPORATION
- Product Code
- FNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MANUFACTURER RECEIVED A REPORT ALLEGING THAT A PT DIED OF ASPHYXIA WHEN THEIR HEAD BECAME LODGED BETWEEN THE FRAME AND THE SIDE RAILS OF THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | MATTRESS | FNM | INVACARE CORPORATION | MATTRESS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death |