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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 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
2018
84
84
2019
90
90
2020
118
118
2021
73
73
2022
51
51
2023
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
242
242
Fracture
33
33
Detachment of Device or Device Component
30
30
Fluid/Blood Leak
26
26
Adverse Event Without Identified Device or Use Problem
23
23
Leak/Splash
21
21
Migration
7
7
Material Deformation
7
7
Device Dislodged or Dislocated
5
5
Unintended Movement
5
5
Material Fragmentation
5
5
Detachment Of Device Component
5
5
Fitting Problem
5
5
Defective Component
4
4
Separation Failure
4
4
Material Rupture
4
4
Material Integrity Problem
4
4
Difficult to Open or Close
3
3
Material Separation
3
3
Disconnection
3
3
Entrapment of Device
3
3
Deformation Due to Compressive Stress
3
3
Migration or Expulsion of Device
3
3
Improper or Incorrect Procedure or Method
3
3
Failure to Infuse
3
3
Obstruction of Flow
2
2
Mechanical Problem
2
2
Reflux within Device
2
2
Difficult to Remove
2
2
Malposition of Device
2
2
Device Slipped
2
2
Difficult to Insert
2
2
Difficult to Advance
2
2
Material Twisted/Bent
2
2
Appropriate Term/Code Not Available
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Premature Separation
2
2
Material Split, Cut or Torn
1
1
Failure to Eject
1
1
Physical Resistance/Sticking
1
1
Separation Problem
1
1
Gas/Air Leak
1
1
Device-Device Incompatibility
1
1
Loose or Intermittent Connection
1
1
Unexpected Therapeutic Results
1
1
Restricted Flow rate
1
1
Difficult to Flush
1
1
Material Disintegration
1
1
Complete Blockage
1
1
Patient-Device Incompatibility
1
1
Component or Accessory Incompatibility
1
1
Defective Device
1
1
Component Missing
1
1
Failure to Advance
1
1
Dent in Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
149
149
No Known Impact Or Consequence To Patient
92
92
No Clinical Signs, Symptoms or Conditions
62
62
Foreign Body In Patient
39
39
Insufficient Information
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Device Embedded In Tissue or Plaque
10
10
No Code Available
9
9
Unspecified Infection
9
9
Abdominal Pain
8
8
Peritonitis
8
8
Pain
8
8
Perforation
5
5
Bowel Perforation
5
5
Hemorrhage/Bleeding
4
4
Erythema
3
3
Erosion
3
3
Seizures
3
3
Post Operative Wound Infection
2
2
Fluid Discharge
2
2
Abdominal Cramps
2
2
Rash
2
2
Granuloma
2
2
Inflammation
2
2
Purulent Discharge
2
2
Internal Organ Perforation
2
2
Necrosis
1
1
Hematoma
1
1
Hypersensitivity/Allergic reaction
1
1
Bradycardia
1
1
Infarction, Cerebral
1
1
Death
1
1
Flatus
1
1
Bacterial Infection
1
1
Local Reaction
1
1
Pocket Erosion
1
1
Therapeutic Response, Decreased
1
1
Discomfort
1
1
Injury
1
1
Skin Inflammation
1
1
Abdominal Distention
1
1
Sleep Dysfunction
1
1
Sepsis
1
1
Perforation of Vessels
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
No Information
1
1
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