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	489	489
Detachment of Device or Device Component	142	142
Torn Material	112	112
Break	91	91
Material Separation	67	67
Detachment Of Device Component	49	49
Adverse Event Without Identified Device or Use Problem	18	18
Difficult to Remove	9	9
Difficult to Insert	7	7
Display or Visual Feedback Problem	4	4
Material Rupture	4	4
Entrapment of Device	3	3
Mechanics Altered	3	3
Defective Device	3	3
Material Fragmentation	3	3
Bent	3	3
Device Difficult to Maintain	3	3
Retraction Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Difficult to Open or Close	2	2
Difficult or Delayed Positioning	2	2
Positioning Problem	2	2
Insufficient Information	2	2
Use of Device Problem	1	1
Device Packaging Compromised	1	1
Failure to Align	1	1
Component Missing	1	1
Optical Problem	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1
Patient Device Interaction Problem	1	1
Smoking	1	1
Loose or Intermittent Connection	1	1
Material Puncture/Hole	1	1
Leak/Splash	1	1
Poor Quality Image	1	1
Material Perforation	1	1
No Display/Image	1	1
Mechanical Problem	1	1
Activation Problem	1	1
Physical Resistance/Sticking	1	1
Product Quality Problem	1	1
Environmental Particulates	1	1
Device Contamination with Chemical or Other Material	1	1
Material Protrusion/Extrusion	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	285	285
No Known Impact Or Consequence To Patient	210	210
No Consequences Or Impact To Patient	201	201
Insufficient Information	62	62
No Information	40	40
No Code Available	33	33
Foreign Body In Patient	24	24
Unspecified Tissue Injury	20	20
No Patient Involvement	11	11
Laceration(s)	5	5
Device Embedded In Tissue or Plaque	5	5
Unintended Radiation Exposure	5	5
Radiation Exposure, Unintended	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Vascular Dissection	3	3
Tissue Damage	3	3
Death	2	2
Pain	2	2
Tissue Breakdown	2	2
Unspecified Infection	1	1
Nausea	1	1
Exsanguination	1	1
Blood Loss	1	1
Rupture	1	1
Post Traumatic Wound Infection	1	1
Injury	1	1
Septic Shock	1	1
Vomiting	1	1
Abscess	1	1
Hemorrhage/Bleeding	1	1

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