TPLC - Total Product Life Cycle

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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	1372	1375
Adverse Event Without Identified Device or Use Problem	351	352
Material Separation	259	264
Detachment of Device or Device Component	96	97
Device Contaminated During Manufacture or Shipping	90	90
Material Split, Cut or Torn	82	82
Delivered as Unsterile Product	47	47
Component Misassembled	38	40
Product Quality Problem	29	29
Device Markings/Labelling Problem	25	25
Manufacturing, Packaging or Shipping Problem	21	21
Material Frayed	20	20
Packaging Problem	17	17
Biocompatibility	17	17
Nonstandard Device	16	16
Defective Component	13	13
Material Discolored	10	10
Dull, Blunt	9	9
Material Integrity Problem	8	8
Defective Device	5	5
Appropriate Device Problem Term/Code Not Available	5	5
Device Slipped	5	5
Material Twisted/Bent	4	4
Insufficient Device Problem Information	4	4
Use of Device Problem	3	3
Component Missing	3	3
Mechanics Altered	2	2
Difficult to Open or Remove Packaging Material	2	2
Corroded	1	1
Patient Device Interaction Problem	1	1
Unraveled Material	1	1
Device Damaged Prior to Use	1	1
Difficult to Remove	1	1
Device Contamination with Chemical or Other Material	1	1
Migration	1	1
Material Too Rigid or Stiff	1	1
Illegible Information	1	2
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1884	1893
Inflammation	175	176
Swelling/ Edema	136	136
Insufficient Information	132	135
Erythema	127	128
Fluid Discharge	99	100
Unspecified Infection	96	96
Pain	96	97
Hemorrhage/Blood Loss/Bleeding	88	88
Purulent Discharge	65	65
Skin Inflammation/ Irritation	49	49
Wound Dehiscence	47	47
Itching Sensation	47	47
Hypersensitivity/Allergic reaction	45	45
Impaired Healing	37	37
Pocket Erosion	24	24
Post Operative Wound Infection	20	20
Local Reaction	17	17
Foreign Body In Patient	15	15
Unspecified Tissue Injury	13	13
Foreign Body Reaction	13	13
Granuloma	12	12
Necrosis	12	12
Fever	11	11
Discomfort	10	10
Abscess	10	10
Hematoma	7	7
Hernia	6	6
Ulcer	5	5
Seroma	5	5
Unintended Radiation Exposure	5	5
Burning Sensation	5	5
Failure to Anastomose	5	5
Fistula	4	4
Eye Injury	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Obstruction/Occlusion	4	4
Thrombosis/Thrombus	3	3
Needle Stick/Puncture	3	3
Adhesion(s)	3	3
Intraocular Pressure Increased	3	3
Chills	3	3
Nerve Damage	3	3
Scar Tissue	3	3
Pneumothorax	3	3
Corneal Edema	3	3
Cyst(s)	3	3
Prolapse	2	2
Perforation of Vessels	2	2
Visual Disturbances	2	2