FDA Adverse Event
Injury
Summary report: N
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
MDR report key: 17532648
·
Received August 12, 2023
Report
- Report Number
- MW5139555
- Event Type
- Injury
- Date Received
- August 12, 2023
- Date of Event
- August 22, 2020
- Report Date
- October 14, 2020
- Manufacturer
- MOXI ENTERPRISES, LLC
- Product Code
- FNM
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DATE RECEIVED NOTICE OF UNUSUAL OCCURRENCE: SEPTEMBER 14, 2020. DESCRIBE THE UNUSUAL OCCURRENCE: RESIDENT FELL OUT OF BED AFTER RECEIVING AIR MATTRESS, FALL RESULTED IN A C7 CERVICAL FRACTURE AND A T2 VERTEBRAL FRACTURE. ACTION REQUIRED: THE MANUFACTURER MOXI WAS NOTIFIED ON OCTOBER 14, 2020. 8326475273. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1216643 | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | MOXI ENTERPRISES, LLC | 1. MAT _A 36X80 MOXI LAL, 2. CU MOXI SA LA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Unknown |