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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, manual, specialized obstetric-gynecologic
Product CodeKNA
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK UROLOGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GLENVEIGH SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 9 9
2016 22 22
2017 37 37
2018 63 63
2019 5 5
2021 2 2
2022 4 4
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 32 32
Material Rupture 18 18
Break 15 15
Inflation Problem 13 13
Hole In Material 12 12
Adverse Event Without Identified Device or Use Problem 8 8
Fluid/Blood Leak 7 7
Deflation Problem 7 7
Burst Container or Vessel 7 7
Device Operates Differently Than Expected 5 5
Detachment Of Device Component 4 4
Other (for use when an appropriate device code cannot be identified) 4 4
Appropriate Term/Code Not Available 4 4
Partial Blockage 3 3
Split 3 3
Component Missing 3 3
Connection Problem 2 2
Detachment of Device or Device Component 2 2
Fracture 2 2
Device Dislodged or Dislocated 2 2
Balloon rupture 2 2
Filling Problem 2 2
Output Problem 2 2
Disconnection 2 2
Blocked Connection 1 1
Material Integrity Problem 1 1
Material Deformation 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Bent 1 1
Packaging Problem 1 1
Defective Component 1 1
Kinked 1 1
Material Puncture/Hole 1 1
Difficult to Open or Close 1 1
Material Fragmentation 1 1
Insufficient Information 1 1
Unintended Ejection 1 1
Torn Material 1 1
Device Operational Issue 1 1
Migration or Expulsion of Device 1 1
Migration 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Separation 1 1
Component(s), broken 1 1
Device Slipped 1 1
Contamination /Decontamination Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contaminated During Manufacture or Shipping 1 1
Fitting Problem 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 53 53
No Consequences Or Impact To Patient 41 41
No Code Available 11 11
Blood Loss 10 10
No Clinical Signs, Symptoms or Conditions 7 7
No Information 6 6
No Patient Involvement 6 6
Hemorrhage/Bleeding 6 6
Necrosis 3 3
Insufficient Information 3 3
Surgical procedure, additional 3 3
Unspecified Infection 2 2
Sepsis 2 2
Uterine Perforation 1 1
Clotting 1 1
Death 1 1
Allergic reaction 1 1
Abnormal Vaginal Discharge 1 1
Coagulation Disorder 1 1
Perforation 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Fever 1 1
Pain 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Stenosis 1 1
Anxiety 1 1
Perforation of Vessels 1 1

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