Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIDIEN MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TRIDIEN MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number TRIDIEN STAT 5000 AP BARI CU, TRIDIEN APL 36X80 MATTRESS
Device Problem Insufficient Information (3190)
Patient Problem Fall (1848)
Event Date 01/25/2018
Event Type  Injury  
Event Description
Facility stating the mattress does not fit the frame correctly, patient has slid out of the bed twice.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
TRIDIEN
MDR Report Key17535600
MDR Text Key321147850
Report NumberMW5142495
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberTRIDIEN STAT 5000 AP BARI CU, TRIDIEN APL 36X80 MATTRESS
Patient Sequence Number1
-
-