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	231	231
Insufficient Information	185	185
Burst Container or Vessel	142	142
Use of Device Problem	66	66
Excessive Heating	63	63
Improper or Incorrect Procedure or Method	45	45
Leak/Splash	29	29
Explosion	24	24
Appropriate Term/Code Not Available	22	22
Fluid/Blood Leak	19	19
Patient-Device Incompatibility	19	19
Material Rupture	17	17
Material Deformation	14	14
Break	12	12
Overheating of Device	11	11
Insufficient Heating	11	11
Temperature Problem	10	10
Off-Label Use	9	9
Defective Device	8	8
Loss of or Failure to Bond	7	7
Material Protrusion/Extrusion	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Patient Device Interaction Problem	6	6
Difficult to Remove	4	4
Therapeutic or Diagnostic Output Failure	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
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	2
Material Split, Cut or Torn	2	2
Premature Activation	2	2
Defective Component	1	1
Material Fragmentation	1	1
Unsealed Device Packaging	1	1
Material Twisted/Bent	1	1
Short Fill	1	1
Device Emits Odor	1	1
Inadequacy of Device Shape and/or Size	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Partial thickness (Second Degree) Burn	197	197
No Clinical Signs, Symptoms or Conditions	190	190
Burn(s)	121	121
Pain	105	105
Burn, Thermal	96	96
Superficial (First Degree) Burn	54	54
Insufficient Information	49	49
Blister	48	48
Erythema	47	47
Chemical Exposure	43	43
Burning Sensation	28	28
No Known Impact Or Consequence To Patient	27	27
Rash	22	22
Itching Sensation	22	22
Full thickness (Third Degree) Burn	17	17
Discomfort	16	16
Peeling	15	15
Skin Discoloration	14	14
Scar Tissue	13	13
Skin Inflammation/ Irritation	13	13
Skin Burning Sensation	12	12
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	7	7
No Consequences Or Impact To Patient	5	5
Hemorrhage/Bleeding	5	5
Caustic/Chemical Burns	5	5
Swelling/ Edema	5	5
Skin Infection	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Fluid Discharge	3	3
Local Reaction	3	3
Purulent Discharge	3	3
Sleep Dysfunction	3	3
Irritation	3	3
Inflammation	3	3
Skin Erosion	3	3
No Code Available	3	3
Reaction	2	2
Tissue Damage	2	2
Blurred Vision	2	2
Fall	2	2
Dyspnea	2	2
Skin Inflammation	2	2