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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
Regulation Description Surgical drape and drape accessories.
Product CodeKGW
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 12 12
2021 4 4
2022 18 18
2023 13 13
2024 19 19
2025 15 15
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 50 50
Device Contaminated During Manufacture or Shipping 14 14
Material Fragmentation 5 5
Material Separation 4 4
Tear, Rip or Hole in Device Packaging 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Break 1 1
Entrapment of Device 1 1
Malposition of Device 1 1
Material Puncture/Hole 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
No Consequences Or Impact To Patient 8 8
No Patient Involvement 4 4
Insufficient Information 2 2
Skin Inflammation/ Irritation 1 1
Peritoneal Laceration(s) 1 1
Thrombosis/Thrombus 1 1
Paresis 1 1
Muscle/Tendon Damage 1 1
Device Embedded In Tissue or Plaque 1 1

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