MAUDE Adverse Event Report: MOXI ENTERPRISES, LLC MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 1. MAT _A 36X80 MOXI LAL, 2. CU MOXI SA LA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/22/2020

Event Type  Injury  

Event Description

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).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI ENTERPRISES, LLC
• MDR Report Key: 17532648
• MDR Text Key: 321137410
• Report Number: MW5139555
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1. MAT _A 36X80 MOXI LAL, 2. CU MOXI SA LA
• Patient Sequence Number: 1
• Patient Age: 65 YR