FDA Adverse Event
Injury
Summary report: N
HILL-ROM TOP SIDERAIL OF BED
MDR report key: 34331
·
Received June 4, 1996
Report
- Report Number
- 34331
- Event Type
- Injury
- Date Received
- June 4, 1996
- Date of Event
- May 31, 1996
- Report Date
- June 3, 1996
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MS, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING NURSING ROUNDS AT 8:00 PM, PT WAS OBSERVED TO BE SLEEPING. DURING ROOM CHECK AT 9:30 PM, PT WAS FOUND WITH HER HEAD THROUGH THE MIDDLE OPENING OF TOP RIGHT BEDRAIL. PT WAS ANXIOUS AND MOVING HEAD FROM SIDE TO SIDE. HEAD BECAME WEDGED IN OPENING AND SIDERAIL HAD TO BE CUT WITH BOLT CUTTERS TO RELEASE HEAD. PT HAD ABRASIONS TO SIDE OF NOSE AND NASAL DISTORTION, AND SOFT TISSUE SWELLING OF CHEEKS AND EYELIDS. NO RESPIRATORY DISTRESS OBSERVED. PT UTILIZED MOUTH BREATHING UNTIL HEAD WAS RELEASED. PT WAS ABLE TO BE TRANSFERRED BACK TO THE NURSING HOME ON 6/3/96.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HILL-ROM TOP SIDERAIL OF BED | TOP SIDERAIL OF BED | FNJ | HILL-ROM, INC. | 1130 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |