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

TPLC - Total Product Life Cycle
  • 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
 

New Search show TPLC since Back to Search Results
Device appliance, colostomy, disposable
Product CodeEZS
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 3 3
2017 1 1
2018 4 4
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Device Operates Differently Than Expected 1 1
Complete Blockage 1 1
Fluid/Blood Leak 1 1
Material Separation 1 1
Increased Sensitivity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4 4
Discomfort 3 3
Skin Irritation 2 2
Fainting 1 1
Unspecified Infection 1 1
Dizziness 1 1
Blood Loss 1 1
Viral Infection 1 1
Urinary Tract Infection 1 1
Skin Inflammation/ Irritation 1 1
Tissue Damage 1 1

-
-