FDA Adverse Event
Death
Summary report: N
SPLIT SIDERAILS
MDR report key: 127218
·
Received October 14, 1997
Report
- Report Number
- 2182305-1997-00013
- Event Type
- Death
- Date Received
- October 14, 1997
- Date of Event
- July 30, 1997
- Report Date
- September 8, 1997
- Manufacturer
- SUNRISE MEDICAL CCG, INC.
- Product Code
- FNJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT TOTAL CARE PT, POSEY SIDE RAIL PADS, WAS FOUND HANGING ON SIDERAIL OF BED. PT'S CHIN NECK AREA WAS CAUGHT ON BED FRAME BETWEEN SPLIT RAILS. DEATH BY ACCIDENTAL ASPHYXIATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPLIT SIDERAILS | SIDERAILS | FNJ | SUNRISE MEDICAL CCG, INC. | F1441 SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Death |