FDA Adverse Event
Death
Summary report: N
INVACARE BEDS
MDR report key: 371006
·
Received January 7, 2002
Report
- Report Number
- 1525712-2002-00004
- Event Type
- Death
- Date Received
- January 7, 2002
- Date of Event
- December 12, 2001
- Report Date
- January 3, 2002
- Manufacturer
- INVAMEX-INVACARE MEXICO
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
RECEIVED MEDWATCH REPORT THAT A RESIDENT WAS ALLEGEDLY FOUND UNRESPONSIVE, HANGING OUT OF THE BED WITH THE RESIDENT'S HEAD THROUGH THE SIDE RAILS BY THE STAFF. THIS EVENT RESULTED IN THE USERS DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE BEDS | * | FNJ | INVAMEX-INVACARE MEXICO | UNKBEDRAIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |