FDA Adverse Event
Injury
Summary report: N
MATTRESS, AIR-FLOTATION, ALTERNATING
MDR report key: 1864703
·
Received October 5, 2010
Report
- Report Number
- 2182305-2010-00041
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- September 9, 2010
- Report Date
- September 30, 2010
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER BY FACILITY; (B)(6), PER FACILITY ONE OF THEIR RESIDENTS FELL OUT OF BED AND RECEIVED CLOSED HEAD TRAUMA, BRUISE TO RIGHT EYE, BRUISE ON ARM AND SHOULDER. NO ONE SAW THE RESIDENT FALL AND SHE MAY HAVE HAD A SEIZURE THAT LEAD UP TO THE INCIDENT. SHE WAS ON AN AIR MATTRESS AT THE TIME WHICH WAS PLACED ON A LOW BED AND BED WAS IN THE LOW POSITION. FACILITY ALSO STATED RESIDENT'S SON IS A LAWYER AND IS VERY ANGRY. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATTRESS, AIR-FLOTATION, ALTERNATING | AIR MATTRESS SYSTEM | FNM | JOERNS HEALTHCARE | DERMAFLOAT APL MATTRESS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |