TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	29	29
Contamination /Decontamination Problem	17	17
Material Separation	17	17
Detachment of Device or Device Component	13	13
Microbial Contamination of Device	8	8
Material Integrity Problem	7	7
Material Fragmentation	7	7
Insufficient Information	6	6
Leak/Splash	4	4
Fracture	3	3
Sparking	3	3
Mechanical Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Peeled/Delaminated	2	2
Crack	2	2
Contamination	2	2
No Apparent Adverse Event	2	2
Calcified	2	2
Optical Obstruction	2	2
Fluid/Blood Leak	1	1
Misfocusing	1	1
Inflation Problem	1	1
Material Deformation	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1
Electrical /Electronic Property Problem	1	1
Separation Problem	1	1
No Display/Image	1	1
Physical Resistance/Sticking	1	1
Material Puncture/Hole	1	1
Material Invagination	1	1
Smoking	1	1
Difficult to Remove	1	1
Component Missing	1	1
Use of Device Problem	1	1
Failure to Power Up	1	1
Material Perforation	1	1
Device Damaged by Another Device	1	1
Blocked Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	46	46
Insufficient Information	26	26
Unspecified Infection	16	16
Foreign Body In Patient	13	13
Bacterial Infection	13	13
No Consequences Or Impact To 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
Unspecified Kidney or Urinary Problem	4	4
Urinary Tract Infection	4	4
Skin Inflammation/ Irritation	2	2
Post Operative Wound Infection	2	2
No Patient Involvement	2	2
Intra-Abdominal Hemorrhage	1	1
Scar Excision	1	1
Burn(s)	1	1
Fever	1	1
Urinary Retention	1	1
Pain	1	1
Unspecified Hepatic or Biliary Problem	1	1
Pneumonia	1	1
Tissue Damage	1	1
Unspecified Heart Problem	1	1
Hemorrhage/Bleeding	1	1
Bruise/Contusion	1	1