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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
  1.  K181643  SmartBag (SmartPouch)

MDR Year MDR Reports MDR Events
2017 20 20
2018 36 36
2019 34 34
2020 22 22
2021 41 41
2022 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 108 108
Patient-Device Incompatibility 33 33
Malposition of Device 9 9
Insufficient Information 6 6
Biocompatibility 4 4
Failure To Adhere Or Bond 3 3
Leak/Splash 3 3
Loss of or Failure to Bond 2 2
Fluid Leak 2 2
Inadequacy of Device Shape and/or Size 2 2
Use of Device Problem 2 2
Device Operates Differently Than Expected 2 2
Inadequate User Interface 1 1
Material Integrity Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Defective Device 1 1
Device Reprocessing Problem 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rash 34 34
Skin Inflammation/ Irritation 30 30
Skin Irritation 25 25
Erythema 19 19
Hypersensitivity/Allergic reaction 15 15
Itching Sensation 13 13
Unspecified Infection 9 9
Urticaria 9 9
No Consequences Or Impact To Patient 8 8
Skin Erosion 6 6
Skin Tears 5 5
Tissue Damage 5 5
Skin Infection 5 5
No Known Impact Or Consequence To Patient 4 4
Fungal Infection 4 4
Abrasion 4 4
Inflammation 3 3
Skin Inflammation 3 3
Blister 3 3
Tissue Breakdown 3 3
Insufficient Information 2 2
Blood Loss 2 2
No Patient Involvement 2 2
Reaction 2 2
Laceration(s) 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Swelling 2 2
Septic Shock 1 1
Pain 1 1
Irritation 1 1
Exposure to Body Fluids 1 1
Cellulitis 1 1
Death 1 1
Urinary Tract Infection 1 1
Burning Sensation 1 1
Discharge 1 1
Wheal(s) 1 1
Pressure Sores 1 1
Anxiety 1 1
Depression 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Contact Dermatitis 1 1

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