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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 200 200
Fracture 33 33
Detachment of Device or Device Component 27 27
Adverse Event Without Identified Device or Use Problem 27 27
Fluid/Blood Leak 25 25
Leak/Splash 8 8
Unintended Movement 8 8
Migration 6 6
Material Deformation 5 5
Device Dislodged or Dislocated 5 5
Premature Separation 5 5
Material Fragmentation 5 5
Entrapment of Device 5 5
Fitting Problem 5 5
Deformation Due to Compressive Stress 4 4
Separation Failure 4 4
Material Rupture 4 4
Material Integrity Problem 4 4
Difficult to Advance 3 3
Difficult to Open or Close 3 3
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 3 3
Material Separation 3 3
Malposition of Device 3 3
Defective Component 3 3
Reflux within Device 2 2
Difficult to Remove 2 2
Obstruction of Flow 2 2
Device Slipped 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 2 2
Disconnection 2 2
Difficult to Insert 2 2
Separation Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Twisted/Bent 2 2
Insufficient Information 2 2
Gas/Air Leak 1 1
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Difficult to Flush 1 1
Restricted Flow rate 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Inadequate or Insufficient Training 1 1
Use of Device Problem 1 1
Failure to Advance 1 1
Dent in Material 1 1
Component Missing 1 1
Failure to Infuse 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Component or Accessory Incompatibility 1 1
Device-Device Incompatibility 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 67 67
No Known Impact Or Consequence To Patient 60 60
Foreign Body In Patient 43 43
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
Bowel Perforation 3 3
Erythema 3 3
Bacterial Infection 3 3
Erosion 3 3
Granuloma 2 2
Inflammation 2 2
Purulent Discharge 2 2
Internal Organ Perforation 2 2
Fluid Discharge 2 2
Abdominal Cramps 2 2
Abdominal Distention 2 2
Sepsis 2 2
Post Operative Wound Infection 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 1 1
Unspecified Blood or Lymphatic problem 1 1
Cough 1 1
Gastrointestinal Hemorrhage 1 1
Melena 1 1
Unspecified Gastrointestinal Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Increased Sensitivity 1 1
Sleep Dysfunction 1 1
Perforation of Vessels 1 1
Pocket Erosion 1 1
Rash 1 1
Local Reaction 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Skin Inflammation 1 1
Necrosis 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Bradycardia 1 1
Infarction, Cerebral 1 1
Death 1 1
Flatus 1 1
Abscess 1 1

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