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 collector, ostomy
Product CodeEXB
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2019 34 34
2020 22 22
2021 41 41
2022 36 36
2023 11 11
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 114 114
Patient-Device Incompatibility 17 17
Insufficient Information 5 5
Inadequacy of Device Shape and/or Size 2 2
Defective Device 2 2
Loss of or Failure to Bond 2 2
Fluid/Blood Leak 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1
Material Separation 1 1
Inadequate User Interface 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 44 44
Rash 29 29
Skin Irritation 22 22
Erythema 18 18
Itching Sensation 16 16
Urticaria 9 9
Skin Infection 9 9
Hypersensitivity/Allergic reaction 7 7
Skin Erosion 5 5
Blister 5 5
Abrasion 4 4
Unspecified Infection 3 3
Laceration(s) 2 2
Tissue Damage 2 2
Contact Dermatitis 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Fungal Infection 2 2
Skin Inflammation 2 2
Blood Loss 2 2
Tissue Breakdown 2 2
No Known Impact Or Consequence To Patient 1 1
Skin Tears 1 1
Pressure Sores 1 1
Swelling 1 1
Skin Burning Sensation 1 1
Urinary Tract Infection 1 1
Burning Sensation 1 1
Concussion 1 1
Wheal(s) 1 1
Abdominal Pain 1 1
Septic Shock 1 1
Pain 1 1
Abscess 1 1
Exposure to Body Fluids 1 1
Cellulitis 1 1
Death 1 1

-
-