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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

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
Burst Container or Vessel 7 7
Deflation Problem 7 7
Device Operates Differently Than Expected 5 5
Other (for use when an appropriate device code cannot be identified) 4 4
Detachment Of Device Component 4 4
Appropriate Term/Code Not Available 4 4
Partial Blockage 3 3
Component Missing 3 3
Split 3 3
Connection Problem 2 2
Detachment of Device or Device Component 2 2
Fracture 2 2
Disconnection 2 2
Filling Problem 2 2
Balloon rupture 2 2
Output Problem 2 2
Device Dislodged or Dislocated 2 2
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Torn Material 1 1
Insufficient Information 1 1
Migration 1 1
Bent 1 1
Component(s), broken 1 1
Unintended Ejection 1 1
Material Fragmentation 1 1
Component Falling 1 1
Kinked 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Component 1 1
Migration or Expulsion of Device 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 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
Hemorrhage/Bleeding 6 6
No Information 6 6
No Patient Involvement 6 6
Surgical procedure, additional 3 3
Necrosis 3 3
Sepsis 2 2
Unspecified Infection 2 2
Insufficient Information 2 2
Laceration(s) 1 1
Clotting 1 1
Uterine Perforation 1 1
Abnormal Vaginal Discharge 1 1
Perforation of Vessels 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Stenosis 1 1
Anxiety 1 1
Pain 1 1
Perforation 1 1
Scar Tissue 1 1
Allergic reaction 1 1
Coagulation Disorder 1 1
Death 1 1
Fever 1 1

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