TPLC - Total Product Life Cycle

• Device: applicator, ent
• Product Code: KCJ
• Regulation Number: 874.5220
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	2	2
2016	2	2
2017	2	2
2018	1	1
2019	3	3
2020	1	1
2021	2	2
2022	3	3
2023	4	4
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Device Operates Differently Than Expected	2	2
Insufficient Information	2	2
Product Quality Problem	2	2
Improper or Incorrect Procedure or Method	1	1
Device Or Device Fragments Location Unknown	1	1
Patient-Device Incompatibility	1	1
Detachment Of Device Component	1	1
Material Discolored	1	1
Fire	1	1
Material Fragmentation	1	1
Mechanical Problem	1	1
Device Emits Odor	1	1
Patient Device Interaction Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Contamination with Chemical or Other Material	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	6	6
Burning Sensation	4	4
Hemorrhage/Bleeding	3	3
Dizziness	3	3
Hypersensitivity/Allergic reaction	2	2
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Chills	1	1
Device Embedded In Tissue or Plaque	1	1
Convulsion/Seizure	1	1
Swelling/ Edema	1	1
Death	1	1
Diarrhea	1	1
Fall	1	1
Fatigue	1	1
Head Injury	1	1
Headache	1	1
Itching Sensation	1	1
Nausea	1	1
Pain	1	1
Perforation	1	1
Blurred Vision	1	1
Vomiting	1	1
No Consequences Or Impact To Patient	1	1
Discomfort	1	1
Injury	1	1
Disability	1	1
Sore Throat	1	1
Loss of consciousness	1	1
Fungal Infection	1	1
Foreign Body In Patient	1	1