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	488	488
Detachment of Device or Device Component	129	129
Material Separation	65	65
Break	61	61
Adverse Event Without Identified Device or Use Problem	14	14
Insufficient Information	6	6
Difficult to Remove	5	5
Device Difficult to Maintain	4	4
Defective Device	4	4
Display or Visual Feedback Problem	4	4
Mechanics Altered	3	3
No Apparent Adverse Event	3	3
Difficult to Insert	3	3
Entrapment of Device	3	3
Difficult to Open or Close	2	2
Material Protrusion/Extrusion	1	1
Optical Problem	1	1
Patient Device Interaction Problem	1	1
Physical Resistance/Sticking	1	1
Activation Problem	1	1
Material Rupture	1	1
Smoking	1	1
Unexpected Therapeutic Results	1	1
Tear, Rip or Hole in Device Packaging	1	1
Leak/Splash	1	1
Mechanical Problem	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Failure to Align	1	1
Device Dislodged or Dislocated	1	1
No Display/Image	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	409	409
Insufficient Information	105	105
No Consequences Or Impact To Patient	80	80
No Information	26	26
Foreign Body In Patient	25	25
Laceration(s)	22	22
Unspecified Tissue Injury	22	22
No Code Available	12	12
Unintended Radiation Exposure	7	7
Tissue Breakdown	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Vascular Dissection	3	3
No Patient Involvement	3	3
Unspecified Infection	2	2
Death	2	2
Device Embedded In Tissue or Plaque	2	2
Exsanguination	1	1
Rupture	1	1
Purulent Discharge	1	1
No Known Impact Or Consequence To Patient	1	1
Post Traumatic Wound Infection	1	1
Injury	1	1
Exposure to Body Fluids	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien Llc	II	Jun-03-2020