TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	269	269
Break	144	144
Mechanical Jam	62	62
Structural Problem	47	47
Naturally Worn	40	40
Physical Resistance/Sticking	20	20
Mechanical Problem	18	18
Detachment of Device or Device Component	17	17
Crack	17	17
Material Twisted/Bent	16	16
Component Missing	15	15
Difficult to Open or Close	15	15
Material Deformation	14	14
Fracture	11	11
Unintended Movement	10	10
Material Integrity Problem	7	7
Appropriate Term/Code Not Available	7	7
Fitting Problem	6	6
Illegible Information	4	4
Device Slipped	4	4
Use of Device Problem	3	3
No Apparent Adverse Event	3	3
Entrapment of Device	3	3
Scratched Material	2	2
Difficult to Remove	2	2
Positioning Failure	2	2
Separation Problem	2	2
Positioning Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Connection Problem	2	2
Contamination /Decontamination Problem	1	1
Incorrect Measurement	1	1
Fluid/Blood Leak	1	1
Loose or Intermittent Connection	1	1
Corroded	1	1
Device Damaged Prior to Use	1	1
Material Disintegration	1	1
Failure to Clean Adequately	1	1
Material Fragmentation	1	1
Insufficient Flow or Under Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	331	331
No Consequences Or Impact To Patient	200	200
Insufficient Information	33	33
No Code Available	27	27
Not Applicable	14	14
No Known Impact Or Consequence To Patient	5	5
Hemorrhage/Bleeding	4	4
Patient Problem/Medical Problem	3	3
No Patient Involvement	3	3
High Blood Pressure/ Hypertension	1	1
Unspecified Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Skin Inflammation/ Irritation	1	1
Epistaxis	1	1
Foreign Body In Patient	1	1
Hyperglycemia	1	1
Anxiety	1	1
Shaking/Tremors	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024