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	462	462
Detachment of Device or Device Component	152	152
Torn Material	151	167
Break	107	110
Material Separation	74	82
Detachment Of Device Component	58	64
Adverse Event Without Identified Device or Use Problem	18	18
Material Rupture	11	11
Difficult to Remove	10	10
Difficult to Insert	6	6
Difficult to Open or Close	5	5
Display or Visual Feedback Problem	4	4
Entrapment of Device	3	3
Material Fragmentation	3	3
Bent	3	3
Defective Device	3	3
Mechanics Altered	3	3
Insufficient Information	3	3
Positioning Problem	2	2
Device Difficult to Maintain	2	2
Tear, Rip or Hole in Device Packaging	2	2
Retraction Problem	2	2
Material Puncture/Hole	2	2
Failure to Charge	2	2
Difficult or Delayed Positioning	2	2
Hole In Material	2	2
Mechanical Problem	2	2
Poor Quality Image	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
No Display/Image	1	1
Component Falling	1	1
Burst Container or Vessel	1	1
Product Quality Problem	1	1
Smoking	1	1
Unexpected Therapeutic Results	1	1
Device Inoperable	1	17
Use of Device Problem	1	1
Material Perforation	1	1
Component Missing	1	1
Failure to Align	1	1
Activation, Positioning or Separation Problem	1	1
Device Dislodged or Dislocated	1	1
Environmental Particulates	1	1
Device Contamination with Chemical or Other Material	1	1
Material Protrusion/Extrusion	1	1
Optical Problem	1	1
Device Packaging Compromised	1	1
Appropriate Term/Code Not Available	1	1
Patient Device Interaction Problem	1	1
Physical Resistance/Sticking	1	1
Activation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	261	261
No Known Impact Or Consequence To Patient	251	273
No Consequences Or Impact To Patient	243	243
Insufficient Information	57	57
No Information	47	70
No Code Available	40	44
Foreign Body In Patient	25	25
Unspecified Tissue Injury	20	20
No Patient Involvement	12	12
Tissue Damage	5	5
Unintended Radiation Exposure	5	5
Device Embedded In Tissue or Plaque	5	5
Radiation Exposure, Unintended	4	4
Vascular Dissection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pain	2	2
Death	2	2
Laceration(s)	2	2
Nausea	1	1
Exsanguination	1	1
Unspecified Infection	1	1
Septic Shock	1	1
Vomiting	1	1
Tissue Breakdown	1	1
Abscess	1	1
Rupture	1	1
Injury	1	1
Post Traumatic Wound Infection	1	1
Blood Loss	1	1

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