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	385	385
Insufficient Information	180	180
Leak/Splash	179	179
Burst Container or Vessel	167	167
Use of Device Problem	135	135
Improper or Incorrect Procedure or Method	109	109
Break	78	78
Excessive Heating	77	77
Patient-Device Incompatibility	76	76
Overheating of Device	44	44
Unintended Ejection	40	40
Fluid/Blood Leak	33	33
Nonstandard Device	33	33
Material Rupture	33	33
Explosion	29	29
Defective Device	28	28
Appropriate Term/Code Not Available	27	27
Temperature Problem	25	25
Insufficient Heating	25	25
Loss of or Failure to Bond	18	18
Material Deformation	16	16
Material Protrusion/Extrusion	11	11
Product Quality Problem	11	11
Off-Label Use	10	10
Material Puncture/Hole	9	9
Material Integrity Problem	9	9
Therapeutic or Diagnostic Output Failure	9	9
Material Split, Cut or Torn	8	8
Physical Resistance/Sticking	8	8
Device Markings/Labelling Problem	7	7
Difficult to Remove	7	7
Unsealed Device Packaging	6	6
Patient Device Interaction Problem	6	6
Unexpected Therapeutic Results	5	5
Activation Problem	4	4
Defective Component	4	4
Expiration Date Error	4	4
Packaging Problem	4	4
Gel Leak	3	3
Device Emits Odor	3	3
Component Missing	3	3
Moisture Damage	3	3
Device Damaged Prior to Use	3	3
Output Problem	3	3
Activation, Positioning or Separation Problem	3	3
Labelling, Instructions for Use or Training Problem	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Detachment of Device or Device Component	2	2
Manufacturing, Packaging or Shipping Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Partial thickness (Second Degree) Burn	307	307
Burn, Thermal	239	241
No Known Impact Or Consequence To Patient	189	189
No Clinical Signs, Symptoms or Conditions	175	175
Pain	170	170
Burn(s)	119	119
Chemical Exposure	85	85
Erythema	80	80
Swelling	68	68
Burning Sensation	54	54
Superficial (First Degree) Burn	50	50
Itching Sensation	50	50
Insufficient Information	48	48
Blister	46	46
Rash	43	43
Skin Irritation	37	37
Discomfort	30	30
Skin Discoloration	28	28
Scarring	28	28
Injury	27	27
Hypersensitivity/Allergic reaction	22	22
Full thickness (Third Degree) Burn	22	22
Peeling	18	18
No Consequences Or Impact To Patient	18	18
Skin Tears	16	16
Ulcer	14	14
Scar Tissue	14	14
No Code Available	13	13
Abrasion	13	13
Urticaria	13	13
Skin Inflammation/ Irritation	12	12
Patient Problem/Medical Problem	12	12
Irritation	12	12
Skin Burning Sensation	12	12
Tissue Damage	11	11
Skin Inflammation	10	10
Hemorrhage/Bleeding	9	9
Caustic/Chemical Burns	8	8
Red Eye(s)	7	7
Reaction	7	7
Inflammation	7	7
Tissue Breakdown	7	7
No Information	6	6
Tingling	6	6
Sleep Dysfunction	6	6
Bruise/Contusion	6	6
Swelling/ Edema	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Skin Infection	5	5
Contusion	5	5