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

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Hematoma (1884); Skin Tears (2516)

Event Date 03/09/2018

Event Type  Injury  

Event Description

Afternoon of (b)(6) 2018, (b)(6) discovered patient had fallen out of bed.They took him to the emergency room.Were there any injuries?: yes.Was medical attention required? yes.What were the injuries?: few skin tears, hematoma on the head.Hospital name: (b)(6).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: 17533024
• MDR Text Key: 321139169
• Report Number: MW5139930
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 80 YR