TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	60	60
Detachment of Device or Device Component	45	45
Mechanical Problem	15	15
Difficult to Open or Close	13	13
Failure to Align	7	7
Difficult to Remove	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Physical Resistance/Sticking	4	4
Material Twisted/Bent	4	4
Mechanics Altered	2	2
Material Split, Cut or Torn	2	2
Product Quality Problem	2	2
Entrapment of Device	2	2
Difficult to Insert	1	1
Human-Device Interface Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Protrusion/Extrusion	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	56	56
No Consequences Or Impact To Patient	20	20
No Patient Involvement	8	8
Unintended Radiation Exposure	7	7
Foreign Body In Patient	7	7
Insufficient Information	5	5
No Information	4	4
Unspecified Tissue Injury	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Constipation	2	2
Syncope/Fainting	2	2
Cramp(s) /Muscle Spasm(s)	2	2
No Known Impact Or Consequence To Patient	2	2
Hematuria	2	2
Fluid Discharge	2	2
Discomfort	2	2
Abdominal Pain	2	2
Emotional Changes	2	2
Erythema	2	2
Nausea	2	2
Pain	2	2
Abnormal Vaginal Discharge	2	2
Dizziness	1	1
Hemorrhage/Bleeding	1	1
Muscle Weakness	1	1
Cellulitis	1	1
Purulent Discharge	1	1
Anxiety	1	1
Sleep Dysfunction	1	1
Dysuria	1	1
Device Embedded In Tissue or Plaque	1	1
No Code Available	1	1