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	500	500
Use of Device Problem	227	228
Insufficient Information	142	142
Break	125	125
Mechanical Problem	114	115
Device Tipped Over	100	100
Device Fell	97	97
Unintended Movement	78	78
Material Split, Cut or Torn	71	71
Appropriate Term/Code Not Available	63	63
Fracture	55	55
Adverse Event Without Identified Device or Use Problem	45	45
Sparking	22	22
Improper or Incorrect Procedure or Method	22	22
Unstable	19	19
Material Deformation	18	18
Unintended System Motion	17	17
Naturally Worn	16	16
Material Twisted/Bent	13	13
Material Rupture	12	12
Component Missing	11	11
Overheating of Device	10	10
Device Slipped	9	9
Material Integrity Problem	9	9
Compatibility Problem	9	9
No Apparent Adverse Event	9	9
Device Handling Problem	8	8
Patient Device Interaction Problem	8	8
Defective Component	8	8
Electrical /Electronic Property Problem	7	7
Disconnection	7	7
Device Dislodged or Dislocated	7	7
Protective Measures Problem	7	7
Crack	6	6
Loose or Intermittent Connection	6	6
Material Separation	6	6
Battery Problem	5	5
Misassembly by Users	5	5
Therapeutic or Diagnostic Output Failure	4	4
Sharp Edges	4	4
Separation Problem	4	4
Unclear Information	4	4
Mechanical Jam	4	5
Installation-Related Problem	4	4
Electrical Shorting	4	4
Material Fragmentation	4	4
Material Frayed	4	4
Collapse	4	4
Component Incompatible	4	4
Fire	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	787	787
Fall	437	439
Bone Fracture(s)	166	166
Head Injury	141	141
Laceration(s)	126	126
Bruise/Contusion	121	121
Insufficient Information	70	70
Pain	62	62
Hematoma	53	53
Hip Fracture	32	32
Hemorrhage/Bleeding	24	24
Multiple Fractures	23	23
Abrasion	22	22
Limb Fracture	21	21
Skin Tears	17	17
Vertebral Fracture	15	15
Unspecified Tissue Injury	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Intracranial Hemorrhage	11	11
Muscle/Tendon Damage	11	11
Swelling/ Edema	11	11
Concussion	10	10
Joint Dislocation	9	9
Physical Entrapment	5	5
Headache	5	5
Skull Fracture	5	5
Electric Shock	5	5
Damage to Ligament(s)	5	5
Anxiety	4	4
Brain Injury	4	4
Erythema	4	4
Tooth Fracture	3	3
Cardiac Arrest	3	3
Discomfort	3	3
Convulsion/Seizure	2	2
Nodule	2	2
No Consequences Or Impact To Patient	2	2
Pressure Sores	2	2
Hemothorax	2	2
Tissue Breakdown	2	2
Pulmonary Embolism	2	2
No Patient Involvement	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

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