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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device collector, ostomy
Product CodeEXB
Regulation Number 876.5900
Device Class 1


Premarket Reviews
ManufacturerDecision
11 HEALTH TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1

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
Inadequacy of Device Shape and/or Size 2 2
Device Operates Differently Than Expected 2 2
Loss of or Failure to Bond 2 2
Fluid Leak 2 2
Use of Device Problem 2 2
Defective Device 1 1
Inadequate User Interface 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Appropriate Term/Code Not Available 1 1
Device Disinfection Or Sterilization Issue 1 1
Patient Device Interaction Problem 1 1
Device Reprocessing Problem 1 1
Device Emits Odor 1 1
Material Integrity Problem 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
Urticaria 9 9
Unspecified Infection 9 9
No Consequences Or Impact To Patient 8 8
Skin Erosion 6 6
Skin Tears 5 5
Skin Infection 5 5
Tissue Damage 5 5
Abrasion 4 4
Fungal Infection 4 4
No Known Impact Or Consequence To Patient 4 4
Tissue Breakdown 3 3
Blister 3 3
Skin Inflammation 3 3
Inflammation 3 3
Swelling 2 2
Hemorrhage/Bleeding 2 2
Reaction 2 2
Blood Loss 2 2
No Patient Involvement 2 2
Laceration(s) 2 2
Fever 2 2
Insufficient Information 2 2
Contact Dermatitis 1 1
Pressure Sores 1 1
Pain 1 1
Burning Sensation 1 1
Anxiety 1 1
Depression 1 1
Impaired Healing 1 1
Exposure to Body Fluids 1 1
Urinary Tract Infection 1 1
Inadequate Pain Relief 1 1
Cellulitis 1 1
Death 1 1
Discharge 1 1
Wheal(s) 1 1
Irritation 1 1
Septic Shock 1 1

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