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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ring (wound protector), drape retention, internal
Product CodeKGW
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2019 11 11
2020 12 12
2021 4 4
2022 18 18
2023 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 27 27
Device Contaminated During Manufacture or Shipping 9 9
Material Fragmentation 4 4
Material Separation 4 4
Tear, Rip or Hole in Device Packaging 4 4
Detachment of Device or Device Component 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 1 1
Device Handling Problem 1 1
Break 1 1
Malposition of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
No Consequences Or Impact To Patient 16 16
No Patient Involvement 5 5
Device Embedded In Tissue or Plaque 2 2
Thrombosis/Thrombus 1 1
Muscle/Tendon Damage 1 1
Skin Inflammation/ Irritation 1 1
Nerve Damage 1 1
Paresis 1 1
Peritoneal Laceration(s) 1 1

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