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	466	466
Use of Device Problem	195	195
Break	137	137
Insufficient Information	111	111
Device Tipped Over	88	88
Mechanical Problem	87	87
Device Fell	78	78
Unintended Movement	72	72
Material Split, Cut or Torn	62	62
Appropriate Term/Code Not Available	58	58
Fracture	49	49
Adverse Event Without Identified Device or Use Problem	48	48
Improper or Incorrect Procedure or Method	28	28
Naturally Worn	19	19
Unintended System Motion	19	19
Material Deformation	18	18
Sparking	18	18
Unstable	15	15
Material Twisted/Bent	15	15
Unclear Information	12	12
Component Missing	11	11
Device Slipped	10	10
Material Separation	10	10
Overheating of Device	10	10
Device Dislodged or Dislocated	10	10
Material Rupture	9	9
Defective Component	9	9
Device Handling Problem	8	8
No Apparent Adverse Event	8	8
Patient Device Interaction Problem	8	8
Therapeutic or Diagnostic Output Failure	8	8
Material Integrity Problem	8	8
Loose or Intermittent Connection	7	7
Crack	6	6
Electrical /Electronic Property Problem	6	6
Installation-Related Problem	6	6
Protective Measures Problem	5	5
Inadequate or Insufficient Training	5	5
Material Fragmentation	5	5
Electrical Shorting	5	5
Misassembly by Users	5	5
Disconnection	5	5
Component Incompatible	4	4
Defective Device	4	4
Off-Label Use	4	4
Contamination /Decontamination Problem	4	4
Fire	4	4
Separation Problem	4	4
Compatibility Problem	4	4
Sharp Edges	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	618	618
Fall	414	414
Bone Fracture(s)	166	166
Head Injury	149	149
Laceration(s)	118	118
Bruise/Contusion	114	114
Pain	61	61
Insufficient Information	58	58
No Consequences Or Impact To Patient	47	47
Hematoma	45	45
No Patient Involvement	41	41
Hip Fracture	25	25
Abrasion	25	25
Limb Fracture	20	20
Death	20	20
Skin Tears	17	17
Hemorrhage/Bleeding	17	17
Unspecified Tissue Injury	15	15
Concussion	12	12
Multiple Fractures	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
No Known Impact Or Consequence To Patient	11	11
Muscle/Tendon Damage	10	10
Intracranial Hemorrhage	10	10
Physical Entrapment	9	9
Swelling/ Edema	9	9
Vertebral Fracture	9	9
Injury	9	9
Electric Shock	5	5
Joint Dislocation	5	5
Skull Fracture	5	5
Headache	4	4
Tooth Fracture	4	4
Bacterial Infection	4	4
Brain Injury	4	4
Fracture, Arm	4	4
Cardiac Arrest	3	3
Swelling	3	3
Damage to Ligament(s)	3	3
Crushing Injury	2	2
Convulsion/Seizure	2	2
Post Traumatic Wound Infection	2	2
Confusion/ Disorientation	2	2
Skin Discoloration	2	2
Loss of consciousness	2	2
Neck Pain	2	2
Pressure Sores	2	2
Chest Pain	2	2
Nausea	2	2
Strangulation	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	I	May-21-2022
2	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	II	Mar-06-2020
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	II	Mar-28-2022
7	Getinge Dominican Republic SA	II	Sep-13-2021
8	Handicare AB	II	Oct-09-2020
9	Handicare AB	II	May-09-2020
10	Hill-Rom, Inc.	II	Mar-11-2022
11	Hill-Rom, Inc.	II	Feb-16-2022
12	Hill-Rom, Inc.	II	Sep-30-2021
13	Hill-Rom, Inc.	I	Jan-29-2021
14	Human Care Hc Sweden Ab	II	Apr-05-2024
15	Human Care USA, Inc.	II	Mar-31-2022
16	Med-Mizer, Inc.	II	Mar-02-2023