TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	222	222
Adverse Event Without Identified Device or Use Problem	143	143
Burst Container or Vessel	139	142
Improper or Incorrect Procedure or Method	42	42
Excessive Heating	37	37
Use of Device Problem	22	22
Appropriate Term/Code Not Available	19	19
Material Rupture	18	18
Leak/Splash	18	19
Explosion	13	13
Fluid/Blood Leak	12	12
Off-Label Use	11	11
Break	9	11
Manufacturing, Packaging or Shipping Problem	9	11
Material Deformation	7	7
Temperature Problem	7	7
Insufficient Heating	7	7
Patient Device Interaction Problem	7	7
Defective Device	5	5
Material Integrity Problem	4	4
Overheating of Device	4	4
Therapeutic or Diagnostic Output Failure	3	3
Activation Failure	3	3
Activation Problem	2	2
Packaging Problem	2	2
Patient-Device Incompatibility	2	2
Premature Activation	2	4
Loss of or Failure to Bond	2	2
Crack	2	2
Unintended Ejection	2	2
Material Frayed	1	1
Gel Leak	1	1
Device Damaged Prior to Use	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Self-Activation or Keying	1	1
Unexpected Therapeutic Results	1	1
Activation, Positioning or Separation Problem	1	1
Improper Chemical Reaction	1	1
Material Protrusion/Extrusion	1	1
Protective Measures Problem	1	1
Output Problem	1	2
Device Handling Problem	1	1
Noise, Audible	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	198	199
Partial thickness (Second Degree) Burn	182	182
Burn(s)	156	156
Pain	83	83
Superficial (First Degree) Burn	64	64
Blister	57	57
Insufficient Information	44	47
Erythema	34	34
Chemical Exposure	32	34
Itching Sensation	20	20
Burning Sensation	18	18
Scar Tissue	17	17
Peeling	16	16
Skin Inflammation/ Irritation	15	15
Skin Discoloration	15	15
Full thickness (Third Degree) Burn	14	14
Skin Burning Sensation	12	12
Ulcer	12	12
Burn, Thermal	10	10
Rash	9	9
Discomfort	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Skin Tears	7	7
Skin Infection	6	6
Hemorrhage/Bleeding	6	6
Abrasion	6	6
Swelling/ Edema	5	5
Bruise/Contusion	4	4
Hypersensitivity/Allergic reaction	4	4
Purulent Discharge	4	4
Local Reaction	4	4
Contact Dermatitis	3	3
Skin Erosion	3	3
Urticaria	3	3
Sleep Dysfunction	3	3
Localized Skin Lesion	3	3
Eye Burn	3	3
Unspecified Infection	2	2
Chills	2	2
Chest Pain	2	2
Skin Disorders	2	2
Dyspnea	2	2
Eye Pain	2	2
Fluid Discharge	2	2
Caustic/Chemical Burns	2	2
Emotional Changes	2	2
Blurred Vision	2	2
Device Embedded In Tissue or Plaque	1	1
Eczema	1	1
Cryogenic Burn	1	1