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	490	490
Break	217	217
Use of Device Problem	182	182
Insufficient Information	97	97
Device Tipped Over	94	94
Unintended Movement	89	89
Device Fell	86	86
Fracture	63	63
Adverse Event Without Identified Device or Use Problem	59	59
Material Split, Cut or Torn	58	58
Appropriate Term/Code Not Available	51	51
Improper or Incorrect Procedure or Method	31	31
Mechanical Problem	31	31
Unstable	29	29
Unintended System Motion	21	21
Naturally Worn	19	19
Material Deformation	18	18
Unclear Information	18	18
Material Twisted/Bent	17	17
Sparking	17	17
Device Dislodged or Dislocated	17	17
Component Missing	14	14
Device Handling Problem	14	14
Material Separation	13	13
Device Slipped	13	13
Material Integrity Problem	11	11
Defective Component	10	10
Overheating of Device	9	9
Material Fragmentation	9	9
Installation-Related Problem	8	8
Loose or Intermittent Connection	8	8
Therapeutic or Diagnostic Output Failure	8	8
Patient Device Interaction Problem	8	8
No Apparent Adverse Event	7	7
Material Rupture	7	7
Positioning Failure	7	7
Inadequate or Insufficient Training	6	6
Protective Measures Problem	6	6
Crack	6	6
Fire	6	6
Electrical /Electronic Property Problem	6	6
Collapse	5	5
Misassembly by Users	5	5
Off-Label Use	4	4
Electrical Shorting	4	4
Component Incompatible	4	4
Arcing	4	4
Compatibility Problem	4	4
Smoking	4	4
Defective Device	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	457	457
No Clinical Signs, Symptoms or Conditions	456	456
Bone Fracture(s)	173	173
Head Injury	159	159
No Consequences Or Impact To Patient	141	141
Laceration(s)	124	124
Bruise/Contusion	115	115
No Patient Involvement	89	89
No Known Impact Or Consequence To Patient	73	73
Pain	65	65
Hematoma	48	48
Insufficient Information	48	48
Death	39	39
Injury	29	29
Hip Fracture	26	26
Abrasion	25	25
Skin Tears	21	21
Limb Fracture	19	19
Hemorrhage/Bleeding	17	17
Unspecified Tissue Injury	14	14
Concussion	14	14
Intracranial Hemorrhage	12	12
Multiple Fractures	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Fracture, Arm	9	9
Muscle/Tendon Damage	9	9
Swelling/ Edema	8	8
Vertebral Fracture	7	7
Physical Entrapment	7	7
No Information	7	7
Swelling	6	6
Electric Shock	5	5
Brain Injury	5	5
Skull Fracture	5	5
Headache	4	4
Bacterial Infection	4	4
Spinal Column Injury	4	4
Contusion	4	4
Patient Problem/Medical Problem	4	4
Damage to Ligament(s)	3	3
Neck Pain	3	3
Suture Abrasion	3	3
Discomfort	3	3
Tooth Fracture	3	3
Ecchymosis	3	3
Hemothorax	3	3
Skin Discoloration	2	2
Post Traumatic Wound Infection	2	2
Confusion/ Disorientation	2	2
Chest Pain	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	Community Products, LLC	II	Oct-22-2019
8	Getinge Dominican Republic SA	II	Sep-13-2021
9	Handicare AB	II	Oct-09-2020
10	Handicare AB	II	May-09-2020
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
18	Moller Vital	II	May-16-2019