TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	25	25
Material Separation	17	17
Contamination /Decontamination Problem	17	17
Detachment of Device or Device Component	11	11
Microbial Contamination of Device	8	8
Material Integrity Problem	7	7
Insufficient Information	6	6
Material Fragmentation	6	6
Leak/Splash	4	4
Mechanical Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Sparking	3	3
Fracture	3	3
Device Contamination with Chemical or Other Material	3	3
No Apparent Adverse Event	2	2
Calcified	2	2
Contamination	2	2
Crack	2	2
Peeled/Delaminated	2	2
Failure to Power Up	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Component Missing	1	1
Smoking	1	1
Material Perforation	1	1
No Display/Image	1	1
Electrical /Electronic Property Problem	1	1
Fluid/Blood Leak	1	1
Misfocusing	1	1
Inflation Problem	1	1
Material Invagination	1	1
Appropriate Term/Code Not Available	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1
Blocked Connection	1	1
Device Damaged by Another Device	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
Insufficient Information	22	22
Unspecified Infection	16	16
Bacterial Infection	13	13
No Consequences Or Impact To Patient	12	12
Foreign Body In Patient	12	12
Patient Problem/Medical Problem	6	6
No Known Impact Or Consequence To Patient	5	5
Device Embedded In Tissue or Plaque	5	5
Urinary Tract Infection	4	4
Unspecified Kidney or Urinary Problem	4	4
Skin Inflammation/ Irritation	2	2
No Patient Involvement	2	2
Scar Excision	1	1
Unspecified Heart Problem	1	1
Intra-Abdominal Hemorrhage	1	1
Unspecified Hepatic or Biliary Problem	1	1
Bruise/Contusion	1	1
Burn(s)	1	1
Fever	1	1
Hemorrhage/Bleeding	1	1
Pain	1	1
Pneumonia	1	1
Tissue Damage	1	1
Urinary Retention	1	1