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	437	437
Detachment of Device or Device Component	126	126
Break	50	50
Material Separation	46	46
Adverse Event Without Identified Device or Use Problem	14	14
Difficult to Remove	7	7
Display or Visual Feedback Problem	4	4
Difficult to Insert	4	4
Entrapment of Device	3	3
Defective Device	3	3
Insufficient Information	2	2
Mechanics Altered	2	2
Material Rupture	1	1
Failure to Align	1	1
Mechanical Problem	1	1
Material Protrusion/Extrusion	1	1
Patient Device Interaction Problem	1	1
Leak/Splash	1	1
Optical Problem	1	1
Physical Resistance/Sticking	1	1
Poor Quality Image	1	1
Tear, Rip or Hole in Device Packaging	1	1
Unexpected Therapeutic Results	1	1
Device Difficult to Maintain	1	1
Activation Problem	1	1
Difficult to Open or Close	1	1
No Display/Image	1	1
Material Puncture/Hole	1	1
Smoking	1	1
Retraction Problem	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	261	261
No Consequences Or Impact To Patient	171	171
Insufficient Information	57	57
No Information	36	36
No Known Impact Or Consequence To Patient	25	25
No Code Available	23	23
Unspecified Tissue Injury	20	20
Foreign Body In Patient	19	19
No Patient Involvement	7	7
Unintended Radiation Exposure	5	5
Vascular Dissection	3	3
Death	2	2
Laceration(s)	2	2
Pain	2	2
Tissue Damage	2	2
Device Embedded In Tissue or Plaque	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Vomiting	1	1
Septic Shock	1	1
Nausea	1	1
Exsanguination	1	1
Unspecified Infection	1	1
Radiation Exposure, Unintended	1	1
Tissue Breakdown	1	1
Rupture	1	1
Injury	1	1
Post Traumatic Wound Infection	1	1

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