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 bag, urinary, ileostomy
Product CodeEXH
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2019 93 93
2020 89 89
2021 2 2
2022 10 10
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 190 190
Material Disintegration 12 12
Positioning Problem 9 9
Fluid/Blood Leak 9 9
Sharp Edges 8 8
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Complete Blockage 2 2
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 162 162
No Clinical Signs, Symptoms or Conditions 28 28
No Patient Involvement 12 12
Discomfort 6 6
Tissue Damage 6 6
Laceration(s) 6 6
Blood Loss 5 5
Hemorrhage/Bleeding 3 3
Urinary Tract Infection 3 3
Erythema 2 2
Cellulitis 1 1
Itching Sensation 1 1
Pain 1 1
Peeling 1 1
Rash 1 1
Swelling 1 1
Burning Sensation 1 1
Chills 1 1
Diaphoresis 1 1
Skin Tears 1 1
Tissue Breakdown 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1

-
-