TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	403	403
Detachment of Device or Device Component	109	109
Material Separation	54	54
Break	52	52
Adverse Event Without Identified Device or Use Problem	12	12
Insufficient Information	6	6
Difficult to Remove	5	5
Display or Visual Feedback Problem	4	4
Defective Device	4	4
Device Difficult to Maintain	4	4
No Apparent Adverse Event	3	3
Mechanics Altered	3	3
Entrapment of Device	3	3
Difficult to Insert	3	3
Difficult to Open or Close	2	2
Material Protrusion/Extrusion	1	1
Smoking	1	1
Unexpected Therapeutic Results	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure to Align	1	1
Leak/Splash	1	1
Mechanical Problem	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Rupture	1	1
No Display/Image	1	1
Activation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	410	410
Insufficient Information	102	102
Foreign Body In Patient	22	22
Laceration(s)	22	22
Unspecified Tissue Injury	22	22
Unintended Radiation Exposure	8	8
Tissue Breakdown	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Vascular Dissection	2	2
Unspecified Infection	1	1
Purulent Discharge	1	1
Rupture	1	1
Post Traumatic Wound Infection	1	1
Exposure to Body Fluids	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	1	1