TPLC - Total Product Life Cycle

show TPLC since

Device	suture, nonabsorbable, silk
Regulation Description	Natural nonabsorbable silk surgical suture.
Product Code	GAP
Regulation Number	878.5030
Device Class	2

Premarket Reviews
Manufacturer	Decision
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
HUAIAN SEAMEN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SAFEPATH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1274	1274
Adverse Event Without Identified Device or Use Problem	342	342
Material Separation	264	264
Detachment of Device or Device Component	113	113
Material Split, Cut or Torn	94	94
Delivered as Unsterile Product	44	44
Device Contaminated During Manufacture or Shipping	43	43
Component Misassembled	31	31
Manufacturing, Packaging or Shipping Problem	29	29
Biocompatibility	17	17
Material Frayed	16	16
Packaging Problem	16	16
Nonstandard Device	15	15
Device Markings/Labelling Problem	15	15
Defective Component	10	10
Material Integrity Problem	10	10
Material Discolored	7	7
Device Slipped	6	6
Product Quality Problem	6	6
Appropriate Term/Code Not Available	5	5
Material Twisted/Bent	5	5
Component Missing	5	5
Defective Device	5	5
Patient-Device Incompatibility	5	5
Insufficient Information	4	4
Migration	3	3
Dull, Blunt	3	3
Mechanics Altered	2	2
Use of Device Problem	2	2
Contamination /Decontamination Problem	2	2
Difficult to Remove	2	2
Difficult to Open or Remove Packaging Material	2	2
Mechanical Problem	2	2
Material Too Rigid or Stiff	1	1
Unraveled Material	1	1
Patient Device Interaction Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Contamination with Chemical or Other Material	1	1
No Apparent Adverse Event	1	1
Illegible Information	1	1
Fracture	1	1
Component Incompatible	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1523	1523
No Consequences Or Impact To Patient	232	232
Inflammation	180	180
Erythema	132	132
Swelling/ Edema	101	101
Pain	90	90
Fluid Discharge	90	90
Unspecified Infection	88	88
Insufficient Information	87	87
Hemorrhage/Bleeding	70	70
Wound Dehiscence	49	49
Purulent Discharge	49	49
Skin Inflammation/ Irritation	43	43
Itching Sensation	40	40
Hypersensitivity/Allergic reaction	38	38
No Known Impact Or Consequence To Patient	32	32
Not Applicable	32	32
Impaired Healing	32	32
Post Operative Wound Infection	20	20
Pocket Erosion	18	18
Foreign Body In Patient	13	13
Foreign Body Reaction	11	11
Fistula	11	11
Fever	11	11
Granuloma	10	10
Local Reaction	10	10
Unspecified Tissue Injury	9	9
Abscess	9	9
No Information	8	8
No Code Available	8	8
Discomfort	8	8
Necrosis	7	7
Blood Loss	7	7
Failure to Anastomose	6	6
Unintended Radiation Exposure	6	6
Scar Tissue	5	5
Ulcer	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hernia	4	4
Bacterial Infection	3	3
Cyst(s)	3	3
Sepsis	3	3
Obstruction/Occlusion	3	3
Burning Sensation	3	3
Pneumothorax	3	3
Eye Injury	3	3
Erosion	2	2
Skin Tears	2	2
Perforation of Vessels	2	2
Corneal Edema	2	2