FDA Adverse Event
Injury
Summary report: N
ALENTI
MDR report key: 1040442
·
Received May 8, 2008
Report
- Report Number
- 9611530-2008-00027
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 25, 2008
- Report Date
- May 8, 2008
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE FACILITY REPORTS, THE LIFT CHAIR WAS IN THE RAISED POSITION. THE CAREGIVER WAS PREPARING TO MANEUVER THE LIFT CHAIR OVER THE TUB, WHEN THE FRONT CASTER FELL OFF. THE RESIDENT WAS WEARING THE SAFETY BELT, AND WAS THEREFORE, STILL SECURED TO THE CHAIR WHEN THE CHAIR FELL. THE RESIDENT HIT HIS ELBOW AND KNEE ON THE FLOOR AND SUSTAINED A LACERATION TO THE LEFT SIDE OF HIS HEAD. THE RESIDENT RECEIVED SUTURES TO CLOSE THE WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALENTI | LIFT HYGIENE CHAIR | FSA | ARJO HOSPITAL EQUIPMENT AB | CDBXXXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |