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

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 11/03/2018

Event Type  Injury  

Event Description

Unwitnessed fall, patient was found on the floor, first time he was trying to reposition himself, second time he was trying to reach something on his bed side and fell, nurse at the facility administered first aid to patient.Were there any injuries? yes.Was medical attention required? yes.What were the injuries? first fall skin tear on right elbow, second fall skin tear on upper left arm.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
• MDR Report Key: 17523449
• MDR Text Key: 321137213
• Report Number: MW5130397
• 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: 11/07/2018

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
• Patient Sequence Number: 1
• Patient Age: 78 YR