TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	244	244
Insufficient Information	207	207
Burst Container or Vessel	142	146
Use of Device Problem	67	67
Excessive Heating	63	63
Improper or Incorrect Procedure or Method	47	47
Leak/Splash	32	33
Explosion	26	26
Appropriate Term/Code Not Available	22	22
Fluid/Blood Leak	19	19
Patient-Device Incompatibility	19	19
Material Rupture	19	20
Material Deformation	14	14
Break	13	15
Insufficient Heating	12	12
Overheating of Device	11	11
Temperature Problem	10	10
Off-Label Use	9	9
Defective Device	8	8
Manufacturing, Packaging or Shipping Problem	8	10
Loss of or Failure to Bond	7	7
Material Protrusion/Extrusion	6	6
Patient Device Interaction Problem	6	6
Therapeutic or Diagnostic Output Failure	5	5
Difficult to Remove	4	4
Material Integrity Problem	4	4
Material Puncture/Hole	4	4
Unintended Ejection	3	3
Activation Problem	3	3
Activation, Positioning or Separation Problem	3	3
Component Missing	2	2
Packaging Problem	2	2
Product Quality Problem	2	2
Activation Failure	2	2
Device Markings/Labelling Problem	2	2
Device Damaged Prior to Use	2	2
Gel Leak	2	2
Physical Resistance/Sticking	2	2
Unexpected Therapeutic Results	2	2
Output Problem	2	3
Material Split, Cut or Torn	2	2
Premature Activation	2	4
Defective Component	1	1
Material Fragmentation	1	1
Unsealed Device Packaging	1	1
Material Twisted/Bent	1	1
Short Fill	1	1
Crack	1	1
Device Emits Odor	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Partial thickness (Second Degree) Burn	206	206
No Clinical Signs, Symptoms or Conditions	197	198
Burn(s)	139	139
Pain	112	112
Burn, Thermal	96	96
Superficial (First Degree) Burn	59	59
Blister	56	56
Insufficient Information	49	52
Erythema	49	50
Chemical Exposure	45	47
Burning Sensation	29	29
No Known Impact Or Consequence To Patient	27	27
Itching Sensation	23	23
Rash	22	22
Full thickness (Third Degree) Burn	17	17
Discomfort	16	16
Peeling	15	15
Scar Tissue	14	14
Skin Discoloration	14	14
Skin Burning Sensation	13	13
Skin Inflammation/ Irritation	13	13
Skin Tears	12	12
Ulcer	12	12
Hypersensitivity/Allergic reaction	11	11
Swelling	11	11
Skin Irritation	10	10
Urticaria	9	9
Injury	9	9
Scarring	8	8
Abrasion	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Skin Infection	6	6
Hemorrhage/Bleeding	6	6
Swelling/ Edema	5	5
Caustic/Chemical Burns	5	5
No Consequences Or Impact To Patient	5	5
Fluid Discharge	4	4
Local Reaction	4	4
Skin Erosion	3	3
Irritation	3	4
Purulent Discharge	3	3
Eye Burn	3	3
Inflammation	3	3
No Code Available	3	3
Sleep Dysfunction	3	3
Blurred Vision	2	2
Localized Skin Lesion	2	2
Skin Disorders	2	2
Emotional Changes	2	2
Eye Pain	2	2