TPLC - Total Product Life Cycle

• Device: exerciser, non-measuring
• Product Code: ION
• Regulation Number: 890.5370
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	3	3
2018	5	5
2019	9	9
2020	6	6
2021	7	7
2022	5	5
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	11	11
Break	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Insufficient Information	3	3
Use of Device Problem	2	2
Detachment of Device or Device Component	2	2
Device Markings/Labelling Problem	1	1
Device Operates Differently Than Expected	1	1
Naturally Worn	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Split	1	1
Burst Container or Vessel	1	1
Crack	1	1
Entrapment of Device	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Unintended System Motion	1	1
Device Slipped	1	1
Inadequate or Insufficient Training	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	8	8
No Clinical Signs, Symptoms or Conditions	7	7
Fall	3	3
Hematoma	3	3
Hemorrhage/Bleeding	2	2
Laceration(s)	2	2
Skin Irritation	2	2
Bone Fracture(s)	2	2
Injury	2	2
Eye Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bruise/Contusion	1	1
Emotional Changes	1	1
Erythema	1	1
Loss of consciousness	1	1
Skin Tears	1	1
Foreign Body In Patient	1	1
No Information	1	1
No Code Available	1	1
Limb Fracture	1	1
Multiple Fractures	1	1
Head Injury	1	1
Headache	1	1
Swelling	1	1
Concussion	1	1