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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 258 258
Fluid Leak 35 35
Fracture 33 33
Leak/Splash 32 32
Detachment of Device or Device Component 28 28
Adverse Event Without Identified Device or Use Problem 17 17
Detachment Of Device Component 16 16
Migration or Expulsion of Device 11 11
Material Fragmentation 6 6
Device Dislodged or Dislocated 6 6
Material Deformation 6 6
Migration 5 5
Material Rupture 5 5
Defective Component 5 5
Improper or Incorrect Procedure or Method 4 4
Delivered as Unsterile Product 4 4
Material Integrity Problem 4 4
Difficult to Open or Close 4 4
Separation Failure 4 4
Device Operates Differently Than Expected 3 3
Difficult to Advance 3 3
Fitting Problem 3 3
Failure to Infuse 3 3
Material Discolored 3 3
Disconnection 3 3
Entrapment of Device 3 3
Hole In Material 2 2
Deflation Problem 2 2
Mechanical Problem 2 2
Reflux within Device 2 2
Difficult to Remove 2 2
Occlusion Within Device 2 2
Material Separation 2 2
Deformation Due to Compressive Stress 2 2
Failure to Advance 2 2
Material Twisted/Bent 2 2
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Premature Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Gas Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Defective Device 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 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
Unsealed Device Packaging 1 1
Obstruction of Flow 1 1
Component Missing 1 1
Loose or Intermittent Connection 1 1
Inflation Problem 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

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 48 48
Foreign Body In Patient 29 29
No Code Available 15 15
Device Embedded In Tissue or Plaque 12 12
Pain 12 12
Insufficient Information 9 9
Peritonitis 8 8
Unspecified Infection 7 7
No Information 7 7
Perforation 6 6
Erythema 5 5
Swelling 5 5
Bowel Perforation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hemorrhage/Bleeding 4 4
Abdominal Pain 3 3
Erosion 3 3
Seizures 3 3
Skin Discoloration 3 3
Injury 3 3
Fluid Discharge 2 2
Rash 2 2
Post Operative Wound Infection 2 2
Burn(s) 2 2
Death 2 2
Purulent Discharge 2 2
Internal Organ Perforation 2 2
Inflammation 2 2
Necrosis 1 1
Fever 1 1
Granuloma 1 1
Hematoma 1 1
Emotional Changes 1 1
Infarction, Cerebral 1 1
Bradycardia 1 1
Bacterial Infection 1 1
Organ Dehiscence 1 1
Sleep Dysfunction 1 1
Abdominal Distention 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Local Reaction 1 1
Pocket Erosion 1 1
Skin Irritation 1 1
Sepsis 1 1
Skin Inflammation 1 1
Gastrointestinal Hemorrhage 1 1
Melena 1 1
Skin Inflammation/ Irritation 1 1

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