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TPLC
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Device
tube, gastro-enterostomy
Product Code
KGC
Regulation Number
876.5980
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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