TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
No Apparent Adverse Event	1035	1038
Detachment of Device or Device Component	600	606
Break	531	531
Insufficient Information	289	289
Loose or Intermittent Connection	230	233
Mechanical Problem	90	90
Device Slipped	88	88
Overheating of Device	88	88
Patient Device Interaction Problem	74	74
Fire	73	73
Electrical /Electronic Property Problem	62	62
Connection Problem	60	60
Material Fragmentation	59	59
Material Separation	54	54
Device Fell	33	33
Arcing	26	26
Naturally Worn	24	24
Smoking	21	21
Temperature Problem	20	20
Product Quality Problem	16	16
Explosion	15	15
Adverse Event Without Identified Device or Use Problem	15	15
Noise, Audible	13	13
Crack	11	11
Device Emits Odor	10	10
Sparking	9	9
Output Problem	9	9
Device Dislodged or Dislocated	9	9
Appropriate Term/Code Not Available	8	8
Vibration	8	8
Degraded	8	8
Thermal Decomposition of Device	8	8
Burst Container or Vessel	7	7
Defective Device	7	7
Separation Problem	6	6
Fitting Problem	6	6
Sharp Edges	6	6
Battery Problem	6	6
Melted	5	5
Excessive Heating	5	5
Material Protrusion/Extrusion	5	5
Charging Problem	5	5
Electrical Shorting	4	4
Inadequacy of Device Shape and/or Size	4	4
Structural Problem	4	4
Use of Device Problem	4	4
Component Missing	4	4
Leak/Splash	4	4
Material Split, Cut or Torn	3	3
Failure to Align	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2199	2203
Unspecified Tissue Injury	209	209
No Consequences Or Impact To Patient	161	161
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	107	107
Tooth Fracture	100	100
Laceration(s)	93	98
Pain	86	86
Hemorrhage/Bleeding	79	79
Choking	72	72
Insufficient Information	72	75
Foreign Body In Patient	70	71
No Known Impact Or Consequence To Patient	55	55
Burn(s)	23	23
Discomfort	21	21
Abrasion	12	12
Electric Shock	11	11
Injury	11	11
Cough	10	10
Skin Inflammation/ Irritation	7	7
Erosion	6	6
Swelling/ Edema	6	6
Sore Throat	5	5
Bruise/Contusion	4	4
Sensitivity of Teeth	4	4
Tinnitus	4	4
Dyspnea	4	4
Itching Sensation	3	3
Vomiting	3	3
No Code Available	3	3
Stomatitis	2	2
Abdominal Pain	2	2
Unspecified Infection	2	2
Superficial (First Degree) Burn	2	2
Bone Fracture(s)	2	2
Viral Infection	2	2
Tissue Damage	2	2
Scar Tissue	2	2
Device Embedded In Tissue or Plaque	1	1
Airway Obstruction	1	1
Eye Pain	1	1
Irritability	1	1
Hypoesthesia	1	1
Headache	1	1
Partial thickness (Second Degree) Burn	1	1
Caustic/Chemical Burns	1	1
Skin Tears	1	1
Ulcer	1	1
Anxiety	1	1
High Blood Pressure/ Hypertension	1	1
Neuropathy	1	1