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TPLC
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Device
instrument, manual, specialized obstetric-gynecologic
Product Code
KNA
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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