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
Detachment of Device or Device Component	13	13
Material Separation	12	12
Microbial Contamination of Device	8	8
Material Integrity Problem	7	7
Insufficient Information	6	6
Material Fragmentation	6	6
Fracture	5	5
Leak/Splash	4	4
Mechanical Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Peeled/Delaminated	2	2
Use of Device Problem	2	2
Component Missing	2	2
No Apparent Adverse Event	2	2
Calcified	2	2
Optical Obstruction	2	2
Sparking	1	1
Separation Problem	1	1
Physical Resistance/Sticking	1	1
Crack	1	1
Material Invagination	1	1
Material Puncture/Hole	1	1
Smoking	1	1
Contamination	1	1
Difficult to Remove	1	1
Failure to Power Up	1	1
Material Perforation	1	1
Blocked Connection	1	1
Device Damaged by Another Device	1	1
Material Deformation	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Electrical /Electronic Property Problem	1	1
Misfocusing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
Insufficient Information	29	29
Unspecified Infection	16	16
Bacterial Infection	13	13
Foreign Body In Patient	10	10
No Consequences Or Impact To Patient	7	7
Unspecified Kidney or Urinary Problem	4	4
Urinary Tract Infection	4	4
Device Embedded In Tissue or Plaque	4	4
Patient Problem/Medical Problem	3	3
Skin Inflammation/ Irritation	2	2
Post Operative Wound Infection	2	2
No Known Impact Or Consequence To Patient	2	2
No Patient Involvement	2	2
Unintended Radiation Exposure	2	2
Intra-Abdominal Hemorrhage	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