TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	254	254
Break	132	132
Mechanical Jam	56	56
Structural Problem	42	42
Naturally Worn	35	35
Physical Resistance/Sticking	20	20
Mechanical Problem	18	18
Crack	16	16
Detachment of Device or Device Component	16	16
Material Twisted/Bent	16	16
Component Missing	15	15
Difficult to Open or Close	15	15
Material Deformation	13	13
Fracture	11	11
Unintended Movement	9	9
Appropriate Term/Code Not Available	7	7
Material Integrity Problem	6	6
Fitting Problem	6	6
Device Slipped	4	4
Illegible Information	4	4
Use of Device Problem	3	3
Entrapment of Device	3	3
Positioning Failure	2	2
Difficult to Remove	2	2
Connection Problem	2	2
Separation Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Positioning Problem	2	2
Scratched Material	2	2
No Apparent Adverse Event	1	1
Insufficient Flow or Under Infusion	1	1
Device Damaged Prior to Use	1	1
Contamination /Decontamination Problem	1	1
Material Disintegration	1	1
Corroded	1	1
Fluid/Blood Leak	1	1
Loose or Intermittent Connection	1	1
Incorrect Measurement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	301	301
No Consequences Or Impact To Patient	200	200
No Code Available	27	27
Insufficient Information	23	23
Not Applicable	14	14
No Known Impact Or Consequence To Patient	5	5
Patient Problem/Medical Problem	3	3
No Patient Involvement	3	3
Hemorrhage/Bleeding	3	3
Hyperglycemia	1	1
Failure of Implant	1	1
Foreign Body In Patient	1	1
Device Embedded In Tissue or Plaque	1	1
Skin Inflammation/ Irritation	1	1

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