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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device collector, ostomy
Regulation Description Ostomy pouch and accessories.
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
2016 20 20
2017 20 20
2018 36 36
2019 34 34
2020 22 22
2021 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 92 92
Patient-Device Incompatibility 36 36
Malposition of Device 9 9
Device Operates Differently Than Expected 8 8
Insufficient Information 7 7
Leak/Splash 5 5
Biocompatibility 4 4
Inadequacy of Device Shape and/or Size 3 3
Failure To Adhere Or Bond 3 3
Loss of or Failure to Bond 2 2
Use of Device Problem 2 2
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Device Reprocessing Problem 1 1
Fluid Leak 1 1
Device Disinfection Or Sterilization Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Inadequate User Interface 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
No Flow 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rash 34 34
Skin Irritation 28 28
Erythema 20 20
Hypersensitivity/Allergic reaction 17 17
Unspecified Infection 14 14
Itching Sensation 12 12
Skin Inflammation/ Irritation 10 10
No Consequences Or Impact To Patient 8 8
Tissue Damage 7 7
Reaction 7 7
Skin Inflammation 6 6
Skin Tears 6 6
Urticaria 6 6
Skin Erosion 5 5
Abrasion 5 5
No Known Impact Or Consequence To Patient 5 5
Skin Infection 5 5
Blood Loss 4 4
Fungal Infection 4 4
Inflammation 4 4
Hemorrhage/Bleeding 4 4
Swelling 4 4
Pain 3 3
Irritation 3 3
Blister 3 3
No Patient Involvement 2 2
Tissue Breakdown 2 2
Laceration(s) 2 2
Fever 2 2
Peeling 2 2
Burning Sensation 2 2
Ulcer 2 2
Discharge 1 1
Wheal(s) 1 1
Pressure Sores 1 1
Anxiety 1 1
Discomfort 1 1
Depression 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Headache 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Skin Discoloration 1 1
Anemia 1 1
Burn(s) 1 1
Cellulitis 1 1
Death 1 1
Post Operative Wound Infection 1 1
No Code Available 1 1
Contact Dermatitis 1 1
Insufficient Information 1 1

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