FDA Adverse Event
Death
Summary report: N
AUTO EXCEL
MDR report key: 495717
·
Received November 17, 2003
Report
- Report Number
- 2431480-2003-00003
- Event Type
- Death
- Date Received
- November 17, 2003
- Date of Event
- November 3, 2003
- Report Date
- November 17, 2003
- Manufacturer
- HUNTLEIGH HEALTHCARE, INC.
- Product Code
- FNM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT'S HEAD FOUND ENTRAPPED IN A HILL-ROM BED RAIL THAT WAS IN USE WITH A HILL-ROM MATTRESS AND HUNTLEIGH HEALTHCARE AUTO-EXCEL OVERLAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO EXCEL | MATTRESS OVERLAY AND PUMP | FNM | HUNTLEIGH HEALTHCARE, INC. | AU1020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death | HILL-ROM ADVANCE 2000 BED FRAME AND MATTRESS. |