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	576	576
Detachment of Device or Device Component	156	156
Material Separation	66	66
Break	65	65
Adverse Event Without Identified Device or Use Problem	16	16
Difficult to Remove	8	8
Insufficient Information	6	6
Difficult to Insert	5	5
Display or Visual Feedback Problem	4	4
Entrapment of Device	3	3
Defective Device	3	3
Device Difficult to Maintain	3	3
Mechanics Altered	3	3
No Apparent Adverse Event	3	3
Material Puncture/Hole	2	2
Difficult to Open or Close	2	2
Leak/Splash	1	1
No Display/Image	1	1
Mechanical Problem	1	1
Physical Resistance/Sticking	1	1
Activation Problem	1	1
Poor Quality Image	1	1
Smoking	1	1
Patient Device Interaction Problem	1	1
Failure to Align	1	1
Material Rupture	1	1
Optical Problem	1	1
Retraction Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Protrusion/Extrusion	1	1
Device Dislodged or Dislocated	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	397	397
No Consequences Or Impact To Patient	171	171
Insufficient Information	99	99
No Information	36	36
Foreign Body In Patient	27	27
No Known Impact Or Consequence To Patient	25	25
No Code Available	23	23
Unspecified Tissue Injury	21	21
Laceration(s)	18	18
No Patient Involvement	7	7
Unintended Radiation Exposure	7	7
Tissue Breakdown	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Vascular Dissection	3	3
Device Embedded In Tissue or Plaque	3	3
Unspecified Infection	2	2
Death	2	2
Pain	2	2
Tissue Damage	2	2
Nausea	1	1
Radiation Exposure, Unintended	1	1
Exsanguination	1	1
Purulent Discharge	1	1
Rupture	1	1
Post Traumatic Wound Infection	1	1
Injury	1	1
Exposure to Body Fluids	1	1
Septic Shock	1	1
Vomiting	1	1
Hemorrhage/Bleeding	1	1

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