FDA Adverse Event
Death
Summary report: N
SIDE RAIL, FULL LENGTH
MDR report key: 73084
·
Received February 28, 1997
Report
- Report Number
- 1523547-1997-90002
- Event Type
- Death
- Date Received
- February 28, 1997
- Date of Event
- December 24, 1993
- Manufacturer
- PCP-CHAMPION
- Product Code
- FNJ
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
CO RECEIVED A CERTIFIED LETTER FROM ATTY, ADVISING THAT THEIR CLIENT WAS FILING SUIT INVOLVING THE DEATH OF A ONE YEAR OLD CHILD. THEY ALLEGE THAT THE CHILD WAS PUT DOWN FOR A NAP ON A HOSP BED WITH BED RAILS. THEY ADVISE THAT THE MOTHER OF THE CHILD RAISED THE RAILS ON THE BED WHEN SHE LAID HIM DOWN TO NAP AND WHEN SHE WENT TO SEE IF HE HAD AWAKENED, HE WAS FOUND WITH HIS HEAD CAUGHT BETWEEN THE TOP RAILS AND THE BED. THE CHILD WAS PLACED IN THE GRANDMOTHER'S HOSP BED TO TAKE A NAP AND WAS UNATTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIDE RAIL, FULL LENGTH | SIDE RAIL, FULL LENGTH | FNJ | PCP-CHAMPION | 6081 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |