TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	237	237
Fracture	34	34
Adverse Event Without Identified Device or Use Problem	28	28
Detachment of Device or Device Component	27	27
Fluid/Blood Leak	25	25
Premature Separation	12	12
Unintended Movement	11	11
Leak/Splash	8	8
Migration	6	6
Fitting Problem	5	5
Entrapment of Device	5	5
Device Dislodged or Dislocated	5	5
Material Deformation	5	5
Material Fragmentation	5	5
Deformation Due to Compressive Stress	4	4
Material Separation	4	4
Material Rupture	4	4
Separation Failure	4	4
Material Integrity Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Difficult to Open or Close	3	3
Appropriate Term/Code Not Available	3	3
Malposition of Device	3	3
Difficult to Advance	3	3
Defective Component	3	3
Material Twisted/Bent	2	2
Obstruction of Flow	2	2
Difficult to Insert	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Difficult to Remove	2	2
Insufficient Information	2	2
Reflux within Device	2	2
Migration or Expulsion of Device	2	2
Mechanical Problem	2	2
Separation Problem	2	2
Device Slipped	2	2
Disconnection	2	2
Defective Device	1	1
Positioning Failure	1	1
Use of Device Problem	1	1
Component Missing	1	1
Patient-Device Incompatibility	1	1
Dent in Material	1	1
Gas/Air Leak	1	1
Difficult to Flush	1	1
Restricted Flow rate	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Failure to Eject	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	110	110
No Clinical Signs, Symptoms or Conditions	97	97
No Known Impact Or Consequence To Patient	60	60
Insufficient Information	47	47
Foreign Body In Patient	47	47
Device Embedded In Tissue or Plaque	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Pain	10	10
Abdominal Pain	9	9
Unspecified Infection	9	9
Peritonitis	9	9
Hemorrhage/Bleeding	7	7
No Code Available	6	6
Perforation	5	5
Skin Inflammation/ Irritation	4	4
Erosion	3	3
Seizures	3	3
Bacterial Infection	3	3
Tachycardia	3	3
Bowel Perforation	3	3
Erythema	3	3
Fever	3	3
Internal Organ Perforation	2	2
Granuloma	2	2
Fluid Discharge	2	2
Post Operative Wound Infection	2	2
Purulent Discharge	2	2
Abdominal Distention	2	2
Abdominal Cramps	2	2
Inflammation	2	2
Gastrointestinal Hemorrhage	2	2
Sepsis	2	2
Skin Infection	2	2
Cramp(s) /Muscle Spasm(s)	1	1
Local Reaction	1	1
Unspecified Blood or Lymphatic problem	1	1
Rash	1	1
Flatus	1	1
Discomfort	1	1
Skin Inflammation	1	1
Hematoma	1	1
Necrosis	1	1
Abscess	1	1
Bradycardia	1	1
Unspecified Gastrointestinal Problem	1	1
Perforation of Vessels	1	1
Cough	1	1
Therapeutic Response, Decreased	1	1
Hypersensitivity/Allergic reaction	1	1
Death	1	1