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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, hemostatic
Product CodeMCH
Regulation Number 878.4300
Device Class 2

MDR Year MDR Reports MDR Events
2018 92 92
2019 77 77
2020 53 53
2021 27 27
2022 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 358 358
Break 23 23
Use of Device Problem 19 19
Device Contamination with Chemical or Other Material 16 16
Difficult to Open or Close 15 15
Material Deformation 10 10
Human-Device Interface Problem 7 7
Premature Activation 7 7
Detachment of Device or Device Component 6 6
Entrapment of Device 5 5
Positioning Failure 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Difficult to Advance 2 2
Appropriate Term/Code Not Available 2 2
Defective Device 2 2
Deformation Due to Compressive Stress 2 2
Material Twisted/Bent 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 179 179
No Clinical Signs, Symptoms or Conditions 159 159
No Known Impact Or Consequence To Patient 38 38
No Patient Involvement 15 15
Hemorrhage/Bleeding 8 8
Syncope/Fainting 1 1
Unspecified Tissue Injury 1 1
Abdominal Pain 1 1
Dizziness 1 1
Anemia 1 1
Ulcer 1 1

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