TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
No Apparent Adverse Event	1075	1078
Detachment of Device or Device Component	602	608
Break	531	531
Insufficient Information	310	310
Loose or Intermittent Connection	230	233
Mechanical Problem	90	90
Device Slipped	88	88
Overheating of Device	87	87
Fire	82	82
Patient Device Interaction Problem	74	74
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	18	18
Adverse Event Without Identified Device or Use Problem	15	15
Explosion	15	15
Noise, Audible	13	13
Crack	11	11
Device Emits Odor	10	10
Device Dislodged or Dislocated	9	9
Output Problem	9	9
Sparking	9	9
Appropriate Term/Code Not Available	8	8
Vibration	8	8
Degraded	8	8
Thermal Decomposition of Device	8	8
Defective Device	7	7
Burst Container or Vessel	7	7
Sharp Edges	6	6
Separation Problem	6	6
Fitting Problem	6	6
Battery Problem	6	6
Material Protrusion/Extrusion	5	5
Excessive Heating	5	5
Melted	5	5
Charging Problem	5	5
Electrical Shorting	4	4
Inadequacy of Device Shape and/or Size	4	4
Structural Problem	4	4
Component Missing	4	4
Use of Device Problem	4	4
Leak/Splash	4	4
Failure to Charge	3	3
Disconnection	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2245	2249
Unspecified Tissue Injury	211	211
No Consequences Or Impact To Patient	161	161
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	124	124
Tooth Fracture	101	101
Laceration(s)	93	98
Pain	86	86
Hemorrhage/Bleeding	80	80
Foreign Body In Patient	74	75
Choking	73	73
Insufficient Information	72	75
No Known Impact Or Consequence To Patient	55	55
Burn(s)	25	25
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
Dyspnea	5	5
Bruise/Contusion	4	4
Sensitivity of Teeth	4	4
Tinnitus	4	4
Itching Sensation	3	3
Vomiting	3	3
No Code Available	3	3
Stomatitis	2	2
Unspecified Infection	2	2
Abdominal Pain	2	2
Superficial (First Degree) Burn	2	2
Ulcer	2	2
Tissue Damage	2	2
Bone Fracture(s)	2	2
Viral Infection	2	2
Scar Tissue	2	2
Device Embedded In Tissue or Plaque	1	1
Airway Obstruction	1	1
Eye Pain	1	1
Headache	1	1
Hypoesthesia	1	1
Irritability	1	1
Skin Infection	1	1
Skin Tears	1	1
Partial thickness (Second Degree) Burn	1	1
Caustic/Chemical Burns	1	1
Anxiety	1	1
High Blood Pressure/ Hypertension	1	1