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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 LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
FIDMI MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 102 102
2018 84 84
2019 90 90
2020 118 118
2021 73 73
2022 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Break 265 265
Fluid/Blood Leak 38 38
Fracture 34 34
Leak/Splash 32 32
Detachment of Device or Device Component 29 29
Adverse Event Without Identified Device or Use Problem 23 23
Detachment Of Device Component 16 16
Migration or Expulsion of Device 12 12
Material Deformation 7 7
Material Integrity Problem 7 7
Migration 6 6
Device Dislodged or Dislocated 6 6
Fitting Problem 6 6
Material Fragmentation 6 6
Material Rupture 5 5
Defective Component 5 5
Separation Failure 4 4
Improper or Incorrect Procedure or Method 4 4
Difficult to Open or Close 4 4
Unintended Movement 4 4
Delivered as Unsterile Product 4 4
Failure to Infuse 3 3
Material Discolored 3 3
Disconnection 3 3
Entrapment of Device 3 3
Device Operates Differently Than Expected 3 3
Difficult to Advance 3 3
Deformation Due to Compressive Stress 3 3
Appropriate Term/Code Not Available 2 2
Material Twisted/Bent 2 2
Hole In Material 2 2
Obstruction of Flow 2 2
Failure to Advance 2 2
Material Separation 2 2
Occlusion Within Device 2 2
Deflation Problem 2 2
Mechanical Problem 2 2
Reflux within Device 2 2
Difficult to Remove 2 2
Unsealed Device Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Stretched 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Dent in Material 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Difficult to Flush 1 1
Restricted Flow rate 1 1
Material Disintegration 1 1
Component Falling 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Premature Separation 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Component Missing 1 1
Defective Device 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 164 164
No Known Impact Or Consequence To Patient 143 143
No Clinical Signs, Symptoms or Conditions 56 56
Foreign Body In Patient 37 37
No Code Available 15 15
Insufficient Information 13 13
Pain 13 13
Device Embedded In Tissue or Plaque 12 12
Unspecified Infection 9 9
Peritonitis 8 8
No Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Perforation 6 6
Swelling 5 5
Erythema 5 5
Bowel Perforation 5 5
Hemorrhage/Bleeding 4 4
Abdominal Pain 4 4
Erosion 3 3
Injury 3 3
Seizures 3 3
Skin Discoloration 3 3
Post Operative Wound Infection 3 3
Fluid Discharge 2 2
Internal Organ Perforation 2 2
Rash 2 2
Burn(s) 2 2
Death 2 2
Purulent Discharge 2 2
Inflammation 2 2
Granuloma 2 2
Hematoma 1 1
Fever 1 1
Necrosis 1 1
Hypersensitivity/Allergic reaction 1 1
Emotional Changes 1 1
Infarction, Cerebral 1 1
Bradycardia 1 1
Bacterial Infection 1 1
Local Reaction 1 1
Pocket Erosion 1 1
Skin Irritation 1 1
Sepsis 1 1
Skin Inflammation 1 1
Perforation of Vessels 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Organ Dehiscence 1 1
Sleep Dysfunction 1 1
Abdominal Cramps 1 1
Abdominal Distention 1 1
Unspecified Blood or Lymphatic problem 1 1
Gastrointestinal Hemorrhage 1 1
Melena 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Increased Sensitivity 1 1
Skin Inflammation/ Irritation 1 1

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