TPLC - Total Product Life Cycle

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Device	tube, gastro-enterostomy
Regulation Description	Gastrointestinal tube and accessories.
Product Code	KGC
Regulation Number	876.5980
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	204	206
Adverse Event Without Identified Device or Use Problem	20	20
Fracture	17	17
Fluid/Blood Leak	15	15
Premature Separation	12	12
Unintended Movement	12	12
Loosening of Implant Not Related to Bone-Ingrowth	9	9
Malposition of Device	8	8
Migration	8	8
Detachment of Device or Device Component	8	9
Fitting Problem	5	5
Entrapment of Device	4	4
Material Separation	4	4
Separation Failure	4	4
Material Deformation	4	4
Difficult to Remove	4	4
Deformation Due to Compressive Stress	3	3
Improper or Incorrect Procedure or Method	3	3
Separation Problem	3	3
Difficult to Open or Close	3	3
Device Dislodged or Dislocated	3	3
Material Rupture	3	3
Defective Component	3	3
Material Integrity Problem	3	4
Material Twisted/Bent	3	3
Appropriate Term/Code Not Available	2	2
Obstruction of Flow	2	2
Difficult to Insert	2	2
Inadequate Instructions for Healthcare Professional	2	2
Insufficient Information	2	2
Reflux within Device	2	2
Migration or Expulsion of Device	2	2
Device Slipped	2	2
Positioning Failure	1	1
Use of Device Problem	1	1
Material Fragmentation	1	1
Dent in Material	1	1
Gas/Air Leak	1	1
Defective Device	1	1
Difficult to Advance	1	1
Difficult to Flush	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Failure to Eject	1	1
Failure to Infuse	1	1
Off-Label Use	1	1
Inadequate or Insufficient Training	1	1
Mechanical Problem	1	1
Loose or Intermittent Connection	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	163	163
Insufficient Information	66	67
Foreign Body In Patient	46	47
Peritonitis	14	14
Device Embedded In Tissue or Plaque	13	13
Abdominal Pain	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Pain	10	10
Hemorrhage/Bleeding	9	9
Unspecified Infection	8	8
Skin Inflammation/ Irritation	7	7
Inflammation	4	4
No Consequences Or Impact To Patient	4	4
Bacterial Infection	4	4
Fever	4	4
Sepsis	3	3
Perforation	3	3
Erosion	3	3
Tachycardia	3	3
Skin Infection	2	2
Gastrointestinal Hemorrhage	2	2
Abdominal Cramps	2	2
Abdominal Distention	2	2
Cough	2	2
Abscess	2	2
Increased Sensitivity	1	1
Aspiration Pneumonitis	1	1
Internal Organ Perforation	1	1
Granuloma	1	1
Perforation of Vessels	1	2
Fluid Discharge	1	1
Bradycardia	1	1
Discomfort	1	1
Vomiting	1	1
Flatus	1	1
Erythema	1	1
Rash	1	1
Unspecified Blood or Lymphatic problem	1	1
Post Operative Wound Infection	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Local Reaction	1	1
Purulent Discharge	1	1
Bowel Perforation	1	1
Unspecified Gastrointestinal Problem	1	1
Hypersensitivity/Allergic reaction	1	1
Death	1	1
Melena	1	1