TPLC - Total Product Life Cycle

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Device	collector, ostomy
Regulation Description	Ostomy pouch and accessories.
Product Code	EXB
Regulation Number	876.5900
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	95	95
Leak/Splash	7	7
Fluid/Blood Leak	5	5
Loss of or Failure to Bond	4	4
Patient Device Interaction Problem	3	3
Lack of Effect	3	3
Insufficient Device Problem Information	3	3
Use of Device Problem	1	1
Unintended Movement	1	1
Biocompatibility	1	1
Human-Device Interface Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Patient-Device Incompatibility	1	1
Difficult to Open or Close	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	63	63
Rash	37	39
Itching Sensation	17	18
Erythema	16	17
Urticaria	12	13
Skin Erosion	9	9
Skin Infection	8	8
Blister	8	8
Urinary Tract Infection	5	5
Tissue Breakdown	4	4
Insufficient Information	4	6
Hypersensitivity/Allergic reaction	4	4
Contact Dermatitis	3	3
No Clinical Signs, Symptoms or Conditions	2	2
Pain	1	1
Abrasion	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Exposure to Body Fluids	1	1
Abscess	1	1
Tissue Irritation	1	1
Pressure Sore/Ulcer	1	1
Sepsis	1	1
Fungal Infection	1	1
Septic Shock	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Burning Sensation	1	2
Abdominal Pain	1	1
Concussion	1	1
Skin Burning Sensation	1	1
Caustic/Chemical Burns	1	1
Death	1	1