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


Premarket Reviews
ManufacturerDecision
11 HEALTH AND TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
11 HEALTH TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 55 55
2015 6 6
2016 20 20
2017 20 20
2018 36 36
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 149 149
Patient-Device Incompatibility 36 36
Insufficient Information 33 33
Human-Device Interface Problem 10 10
Malposition of Device 9 9
Device Operates Differently Than Expected 9 9
Leak/Splash 7 7
Inadequacy of Device Shape and/or Size 5 5
Biocompatibility 4 4
Fluid/Blood Leak 4 4
Use of Device Problem 3 3
Failure To Adhere Or Bond 3 3
Loss of or Failure to Bond 3 3
No Flow 3 3
Loose or Intermittent Connection 2 2
Defective Device 2 2
Device Disinfection Or Sterilization Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Occlusion Within Device 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Material Separation 1 1
Device Reprocessing Problem 1 1
Partial Blockage 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Inadequate User Interface 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rash 55 55
Skin Inflammation/ Irritation 44 44
Skin Irritation 38 38
Erythema 38 38
Itching Sensation 38 38
Hypersensitivity/Allergic reaction 22 22
Unspecified Infection 15 15
Skin Discoloration 10 10
Skin Erosion 9 9
Skin Infection 9 9
Urticaria 9 9
Reaction 8 8
Skin Inflammation 8 8
No Consequences Or Impact To Patient 8 8
Swelling 8 8
Tissue Damage 8 8
Skin Tears 7 7
Fungal Infection 7 7
No Known Impact Or Consequence To Patient 7 7
Hemorrhage/Bleeding 6 6
Abrasion 6 6
Irritation 5 5
Pain 5 5
Blister 5 5
Tissue Breakdown 5 5
Blood Loss 4 4
Burning Sensation 4 4
Inflammation 4 4
Discharge 3 3
Fluid Discharge 3 3
Ulcer 3 3
No Code Available 2 2
Contact Dermatitis 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Patient Involvement 2 2
Discomfort 2 2
Peeling 2 2
Fever 2 2
Laceration(s) 2 2
Abscess 2 2
Death 2 2
Emotional Changes 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Anemia 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Cellulitis 1 1
Headache 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Ulceration 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Hernia 1 1
Wheal(s) 1 1
Concussion 1 1
Injury 1 1
Depression 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Pressure Sores 1 1
Anxiety 1 1
Sleep Dysfunction 1 1
Post Operative Wound Infection 1 1
No Information 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II Sep-09-2011
2 Convatec Inc. III Oct-05-2011
3 Convatec Inc. III Mar-08-2011
-
-