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	115	115
Patient-Device Incompatibility	6	9
Fluid/Blood Leak	6	6
Insufficient Information	4	4
Loss of or Failure to Bond	4	4
Defective Device	3	3
Lack of Effect	3	3
Patient Device Interaction Problem	2	2
Leak/Splash	1	1
Unintended Movement	1	1
Therapeutic or Diagnostic Output Failure	1	3
Use of Device Problem	1	1
Product Quality Problem	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Human-Device Interface Problem	1	1
Difficult to Open or Close	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	52	52
Rash	36	38
Itching Sensation	17	18
Skin Irritation	15	15
Erythema	14	15
Skin Infection	10	10
Urticaria	9	10
Skin Erosion	9	9
Blister	8	8
Hypersensitivity/Allergic reaction	4	4
Abrasion	4	4
Tissue Breakdown	4	4
Urinary Tract Infection	4	4
Insufficient Information	3	5
No Clinical Signs, Symptoms or Conditions	2	2
Contact Dermatitis	2	2
Pressure Sores	2	2
Abdominal Pain	1	1
Death	1	1
Fungal Infection	1	1
Sepsis	1	1
Blood Loss	1	1
Burning Sensation	1	2
Unspecified Mental, Emotional or Behavioural Problem	1	1
Swelling	1	1
Septic Shock	1	1
Exposure to Body Fluids	1	1
Concussion	1	1
Pain	1	1
Abscess	1	1
Caustic/Chemical Burns	1	1
Hemorrhage/Bleeding	1	1
Skin Burning Sensation	1	1