TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	52	52
Detachment of Device or Device Component	50	50
Mechanical Problem	12	12
Difficult to Open or Close	10	10
Difficult to Remove	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Physical Resistance/Sticking	4	4
Material Twisted/Bent	3	3
Failure to Align	3	3
Material Split, Cut or Torn	2	2
Mechanics Altered	2	2
Product Quality Problem	2	2
Entrapment of Device	2	2
Material Protrusion/Extrusion	1	1
Insufficient Device Problem Information	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76	76
Unintended Radiation Exposure	9	9
Insufficient Information	8	8
Foreign Body In Patient	7	7
Unspecified Tissue Injury	3	3
Syncope/Fainting	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Pain	2	2
Abnormal Vaginal Discharge	2	2
Fluid Discharge	2	2
Emotional Changes	2	2
Hematuria	2	2
Nausea	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Abdominal Pain	2	2
Discomfort	2	2
Constipation	2	2
Erythema	2	2
Anxiety	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Cellulitis	1	1
Device Embedded In Tissue or Plaque	1	1
Muscle Weakness/Atrophy	1	1
Dysuria	1	1
Laceration(s)	1	1
Purulent Discharge	1	1
Sleep Dysfunction	1	1
Dizziness	1	1