FDA Adverse Event
Death
Summary report: N
2183191-1996-00001
MDR report key: 44577
·
Received October 18, 1996
Report
- Report Number
- 2183191-1996-00001
- Event Type
- Death
- Date Received
- October 18, 1996
- Date of Event
- September 22, 1996
- Product Code
- INX
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
CO WAS NOTIFIED OF EVENT AFTER THE FACT - INITIAL REPORT DID NOT MENTION BED AND RAIL. PER REPORT RAIL WAS LATCHED IN UP POSITION; IT WAS THE FACILITY'S FEELING THAT THE RAIL AND BED WERE IN GOOD OPERATING CONDITION AND MATTRESS OVERLAY DEVICE MAY HAVE CONTRIBUTED TO RESIDENT GETTING HIS BODY WEDGED BETWEEN BED RAIL AND MATTRESS. CO IS CURRENTLY EVALUATING SPACE BETWEEN VERTICAL BARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |