TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	208	208
Burst Container or Vessel	136	139
Adverse Event Without Identified Device or Use Problem	133	133
Improper or Incorrect Procedure or Method	39	39
Excessive Heating	37	37
Use of Device Problem	21	21
Appropriate Term/Code Not Available	19	19
Material Rupture	17	17
Leak/Splash	16	17
Explosion	13	13
Fluid/Blood Leak	12	12
Off-Label Use	10	10
Break	9	11
Manufacturing, Packaging or Shipping Problem	8	10
Temperature Problem	7	7
Material Deformation	7	7
Patient Device Interaction Problem	6	6
Insufficient Heating	5	5
Material Integrity Problem	4	4
Overheating of Device	3	3
Defective Device	3	3
Premature Activation	2	4
Loss of or Failure to Bond	2	2
Activation Failure	2	2
Packaging Problem	2	2
Unintended Ejection	2	2
Therapeutic or Diagnostic Output Failure	2	2
Patient-Device Incompatibility	2	2
Activation Problem	2	2
Device Handling Problem	1	1
Material Protrusion/Extrusion	1	1
Difficult to Remove	1	1
Protective Measures Problem	1	1
Material Puncture/Hole	1	1
Gel Leak	1	1
Device Damaged Prior to Use	1	1
Unexpected Therapeutic Results	1	1
Crack	1	1
Self-Activation or Keying	1	1
Improper Chemical Reaction	1	1
Output Problem	1	2
Material Split, Cut or Torn	1	1
Activation, Positioning or Separation Problem	1	1
Material Frayed	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	189	190
Partial thickness (Second Degree) Burn	175	175
Burn(s)	139	139
Pain	76	76
Superficial (First Degree) Burn	59	59
Blister	53	53
Insufficient Information	43	46
Erythema	33	33
Chemical Exposure	31	33
Itching Sensation	19	19
Burning Sensation	18	18
Peeling	15	15
Skin Inflammation/ Irritation	15	15
Scar Tissue	14	14
Full thickness (Third Degree) Burn	13	13
Skin Discoloration	13	13
Skin Burning Sensation	12	12
Ulcer	12	12
Burn, Thermal	10	10
Rash	9	9
Skin Tears	7	7
Discomfort	7	7
Skin Infection	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Hemorrhage/Bleeding	6	6
Abrasion	6	6
Swelling/ Edema	5	5
Hypersensitivity/Allergic reaction	4	4
Local Reaction	4	4
Skin Erosion	3	3
Urticaria	3	3
Eye Burn	3	3
Purulent Discharge	3	3
Bruise/Contusion	2	2
Sleep Dysfunction	2	2
Skin Disorders	2	2
Localized Skin Lesion	2	2
Chest Pain	2	2
Dyspnea	2	2
Eye Pain	2	2
Caustic/Chemical Burns	2	2
Fluid Discharge	2	2
Blurred Vision	2	2
Emotional Changes	2	2
Device Embedded In Tissue or Plaque	1	1
Eczema	1	1
Cryogenic Burn	1	1
Loss of Vision	1	1
Headache	1	1
Abdominal Pain	1	1