TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	467	467
Use of Device Problem	209	210
Insufficient Information	134	134
Break	119	119
Mechanical Problem	102	103
Device Tipped Over	91	91
Device Fell	74	74
Unintended Movement	67	67
Material Split, Cut or Torn	64	64
Appropriate Term/Code Not Available	60	60
Fracture	50	50
Adverse Event Without Identified Device or Use Problem	39	39
Improper or Incorrect Procedure or Method	22	22
Sparking	20	20
Material Deformation	18	18
Unintended System Motion	17	17
Unstable	16	16
Naturally Worn	16	16
Material Twisted/Bent	13	13
Material Rupture	12	12
Component Missing	11	11
Overheating of Device	10	10
Compatibility Problem	9	9
Device Slipped	8	8
No Apparent Adverse Event	8	8
Device Handling Problem	8	8
Patient Device Interaction Problem	8	8
Material Integrity Problem	8	8
Defective Component	7	7
Disconnection	7	7
Loose or Intermittent Connection	6	6
Electrical /Electronic Property Problem	6	6
Device Dislodged or Dislocated	6	6
Material Separation	6	6
Crack	5	5
Battery Problem	5	5
Collapse	4	4
Unclear Information	4	4
Material Frayed	4	4
Component Incompatible	4	4
Therapeutic or Diagnostic Output Failure	4	4
Protective Measures Problem	4	4
Separation Problem	4	4
Material Fragmentation	4	4
Installation-Related Problem	4	4
Electrical Shorting	4	4
Misassembly by Users	4	4
Sharp Edges	4	4
Noise, Audible	3	3
Mechanical Jam	3	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	720	720
Fall	397	399
Bone Fracture(s)	147	147
Head Injury	134	134
Laceration(s)	118	118
Bruise/Contusion	117	117
Insufficient Information	66	66
Pain	59	59
Hematoma	49	49
Hip Fracture	29	29
Hemorrhage/Bleeding	22	22
Limb Fracture	20	20
Abrasion	19	19
Multiple Fractures	18	18
Skin Tears	16	16
Unspecified Tissue Injury	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Swelling/ Edema	11	11
Muscle/Tendon Damage	11	11
Intracranial Hemorrhage	11	11
Vertebral Fracture	10	10
Concussion	10	10
Joint Dislocation	7	7
Electric Shock	5	5
Skull Fracture	5	5
Headache	5	5
Damage to Ligament(s)	4	4
Brain Injury	4	4
Anxiety	4	4
Physical Entrapment	4	4
Tooth Fracture	3	3
Cardiac Arrest	3	3
Pulmonary Embolism	2	2
Tissue Breakdown	2	2
Hemothorax	2	2
Pressure Sores	2	2
No Consequences Or Impact To Patient	2	2
Convulsion/Seizure	2	2
Nodule	2	2
No Patient Involvement	2	2
Discomfort	2	2
Strangulation	2	2
Neck Pain	2	2
Movement Disorder	2	2
Confusion/ Disorientation	2	2
Skin Discoloration	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Eye Burn	2	2
Crushing Injury	2	2
Nausea	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	I	May-21-2022
2	Arjohuntleigh Magog, Inc.	II	May-24-2023
3	Arjohuntleigh Magog, Inc.	II	Sep-16-2021
4	Arjohuntleigh Magog, Inc.	II	Feb-09-2021
5	Baxter Healthcare Corporation	I	Jul-09-2025
6	Baxter Healthcare Corporation	II	Mar-28-2022
7	Community Products, LLC	II	Jan-22-2026
8	Getinge Dominican Republic SA	II	Sep-13-2021
9	Hill-Rom, Inc.	II	Mar-11-2022
10	Hill-Rom, Inc.	II	Feb-16-2022
11	Hill-Rom, Inc.	II	Sep-30-2021
12	Hill-Rom, Inc.	I	Jan-29-2021
13	Human Care Hc Sweden Ab	II	Apr-05-2024
14	Human Care USA, Inc.	II	Mar-31-2022
15	Med-Mizer, Inc.	II	Mar-02-2023