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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
2017 58 58
2018 13 13
2019 11 11
2020 12 12
2021 4 4
2022 18 18
2023 13 13
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Perforation 49 49
Material Split, Cut or Torn 30 30
Device Contaminated During Manufacture or Shipping 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Separation 6 6
Material Fragmentation 5 5
Detachment of Device or Device Component 4 4
Break 3 3
Detachment Of Device Component 3 3
Use of Device Problem 2 2
Device Operates Differently Than Expected 2 2
Device Dislodged or Dislocated 2 2
Torn Material 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Malposition of Device 1 1
Particulates 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 61 61
No Clinical Signs, Symptoms or Conditions 32 32
No Known Impact Or Consequence To Patient 21 21
No Patient Involvement 7 7
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Thrombosis/Thrombus 1 1
Muscle/Tendon Damage 1 1
Skin Inflammation/ Irritation 1 1
Injury 1 1
Weight Changes 1 1
Abdominal Pain 1 1
Nerve Damage 1 1
Paresis 1 1
Peritoneal Laceration(s) 1 1
Tissue Damage 1 1

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