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

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

(b)(6) states that she was advised the patient fell over the weekend, and had no other details.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): TRIDIEN
• MDR Report Key: 17525565
• MDR Text Key: 321055544
• Report Number: MW5132506
• 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: 07/04/2018

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