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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, gastro-enterostomy
Product CodeKGC
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
COAPTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
COAPTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
FIDMI MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 90 90
2020 118 118
2021 73 73
2022 51 51
2023 36 36
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Break 203 203
Fracture 34 34
Adverse Event Without Identified Device or Use Problem 27 27
Detachment of Device or Device Component 27 27
Fluid/Blood Leak 25 25
Unintended Movement 8 8
Leak/Splash 8 8
Migration 6 6
Material Deformation 5 5
Device Dislodged or Dislocated 5 5
Material Fragmentation 5 5
Premature Separation 5 5
Fitting Problem 5 5
Entrapment of Device 5 5
Material Rupture 4 4
Separation Failure 4 4
Material Integrity Problem 4 4
Material Separation 4 4
Deformation Due to Compressive Stress 4 4
Difficult to Advance 3 3
Defective Component 3 3
Appropriate Term/Code Not Available 3 3
Difficult to Open or Close 3 3
Improper or Incorrect Procedure or Method 3 3
Malposition of Device 3 3
Obstruction of Flow 2 2
Material Twisted/Bent 2 2
Difficult to Insert 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Difficult to Remove 2 2
Migration or Expulsion of Device 2 2
Reflux within Device 2 2
Mechanical Problem 2 2
Separation Problem 2 2
Device Slipped 2 2
Disconnection 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 1 1
Device-Device Incompatibility 1 1
Component or Accessory Incompatibility 1 1
Physical Resistance/Sticking 1 1
Failure to Eject 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Inadequate or Insufficient Training 1 1
Failure to Advance 1 1
Failure to Infuse 1 1
Use of Device Problem 1 1
Defective Device 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 110 110
No Clinical Signs, Symptoms or Conditions 70 70
No Known Impact Or Consequence To Patient 60 60
Foreign Body In Patient 44 44
Insufficient Information 30 30
Device Embedded In Tissue or Plaque 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Abdominal Pain 9 9
Unspecified Infection 9 9
Hemorrhage/Bleeding 7 7
Peritonitis 7 7
Pain 7 7
No Code Available 6 6
Perforation 5 5
Seizures 3 3
Bacterial Infection 3 3
Erosion 3 3
Bowel Perforation 3 3
Erythema 3 3
Skin Infection 2 2
Granuloma 2 2
Internal Organ Perforation 2 2
Sepsis 2 2
Abdominal Distention 2 2
Inflammation 2 2
Abdominal Cramps 2 2
Purulent Discharge 2 2
Post Operative Wound Infection 2 2
Fluid Discharge 2 2
Increased Sensitivity 1 1
Pocket Erosion 1 1
Therapeutic Response, Decreased 1 1
Cough 1 1
Perforation of Vessels 1 1
Abscess 1 1
Bradycardia 1 1
Discomfort 1 1
Flatus 1 1
Skin Inflammation 1 1
Rash 1 1
Unspecified Blood or Lymphatic problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Local Reaction 1 1
Hematoma 1 1
Skin Inflammation/ Irritation 1 1
Necrosis 1 1
Unspecified Gastrointestinal Problem 1 1
Gastrointestinal Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Death 1 1

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