TPLC - Total Product Life Cycle

show TPLC since

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	207	207
Fracture	34	34
Detachment of Device or Device Component	27	27
Adverse Event Without Identified Device or Use Problem	27	27
Fluid/Blood Leak	25	25
Premature Separation	12	12
Unintended Movement	11	11
Leak/Splash	8	8
Migration	6	6
Device Dislodged or Dislocated	5	5
Material Deformation	5	5
Material Fragmentation	5	5
Entrapment of Device	5	5
Fitting Problem	5	5
Separation Failure	4	4
Deformation Due to Compressive Stress	4	4
Material Rupture	4	4
Material Separation	4	4
Material Integrity Problem	4	4
Difficult to Advance	3	3
Difficult to Open or Close	3	3
Appropriate Term/Code Not Available	3	3
Malposition of Device	3	3
Defective Component	3	3
Improper or Incorrect Procedure or Method	3	3
Disconnection	2	2
Reflux within Device	2	2
Difficult to Remove	2	2
Obstruction of Flow	2	2
Device Slipped	2	2
Mechanical Problem	2	2
Migration or Expulsion of Device	2	2
Difficult to Insert	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Insufficient Information	2	2
Material Twisted/Bent	2	2
Separation Problem	2	2
Gas/Air Leak	1	1
Device-Device Incompatibility	1	1
Material Split, Cut or Torn	1	1
Failure to Eject	1	1
Physical Resistance/Sticking	1	1
Difficult to Flush	1	1
Restricted Flow rate	1	1
Positioning Failure	1	1
Off-Label Use	1	1
Loose or Intermittent Connection	1	1
Inadequate or Insufficient Training	1	1
Use of Device Problem	1	1
Failure to Advance	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	73	73
No Known Impact Or Consequence To Patient	60	60
Foreign Body In Patient	44	44
Insufficient Information	37	37
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
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
Gastrointestinal Hemorrhage	1	1
Perforation of Vessels	1	1
Cough	1	1
Therapeutic Response, Decreased	1	1
Hypersensitivity/Allergic reaction	1	1
Death	1	1