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	1235	1238
Adverse Event Without Identified Device or Use Problem	336	337
Material Separation	240	245
Detachment of Device or Device Component	89	90
Material Split, Cut or Torn	75	75
Device Contaminated During Manufacture or Shipping	60	60
Delivered as Unsterile Product	45	45
Component Misassembled	37	39
Device Markings/Labelling Problem	23	23
Manufacturing, Packaging or Shipping Problem	21	21
Material Frayed	18	18
Packaging Problem	17	17
Biocompatibility	17	17
Nonstandard Device	15	15
Defective Component	13	13
Material Discolored	8	8
Material Integrity Problem	6	6
Product Quality Problem	6	6
Device Slipped	5	5
Patient-Device Incompatibility	5	5
Defective Device	5	5
Appropriate Term/Code Not Available	5	5
Insufficient Information	4	4
Component Missing	3	3
Material Twisted/Bent	3	3
Dull, Blunt	3	3
Difficult to Open or Remove Packaging Material	2	2
Difficult to Remove	2	2
Use of Device Problem	2	2
Mechanics Altered	2	2
Device Damaged Prior to Use	1	1
Patient Device Interaction Problem	1	1
Unraveled Material	1	1
Material Too Rigid or Stiff	1	1
Device Contamination with Chemical or Other Material	1	1
Migration	1	1
Illegible Information	1	2
Fracture	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1657	1666
Inflammation	165	166
Swelling/ Edema	122	122
Erythema	115	116
Insufficient Information	114	117
Fluid Discharge	92	93
Unspecified Infection	91	91
Pain	91	92
Hemorrhage/Bleeding	87	87
Purulent Discharge	62	62
Skin Inflammation/ Irritation	47	47
Wound Dehiscence	45	45
Hypersensitivity/Allergic reaction	45	45
Itching Sensation	44	44
Impaired Healing	33	33
Pocket Erosion	21	21
Post Operative Wound Infection	18	18
Local Reaction	14	14
Foreign Body In Patient	14	14
Unspecified Tissue Injury	12	12
Foreign Body Reaction	12	12
Necrosis	11	11
Granuloma	11	11
Fever	11	11
Discomfort	10	10
Abscess	9	9
Hematoma	5	5
Unintended Radiation Exposure	5	5
Failure to Anastomose	5	5
Ulcer	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hernia	4	4
Seroma	4	4
Burning Sensation	4	4
Corneal Edema	3	3
Eye Injury	3	3
Scar Tissue	3	3
Pneumothorax	3	3
Nerve Damage	3	3
Thrombosis/Thrombus	3	3
Chills	3	3
Obstruction/Occlusion	3	3
Fistula	3	3
Needle Stick/Puncture	2	2
Cancer	2	2
Erosion	2	2
Urinary Retention	2	2
Numbness	2	2
Skin Tears	2	2
Prolapse	2	2