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	1370	1373
Adverse Event Without Identified Device or Use Problem	362	363
Material Separation	257	262
Detachment of Device or Device Component	97	98
Device Contaminated During Manufacture or Shipping	88	88
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	19	19
Packaging Problem	17	17
Biocompatibility	17	17
Nonstandard Device	15	15
Defective Component	13	13
Material Discolored	10	10
Dull, Blunt	9	9
Material Integrity Problem	8	8
Device Slipped	5	5
Patient-Device Incompatibility	5	5
Defective Device	5	5
Appropriate Term/Code Not Available	5	5
Insufficient Information	4	4
Use of Device Problem	4	4
Material Twisted/Bent	4	4
Component Missing	3	3
Difficult to Open or Remove Packaging Material	2	2
Difficult to Remove	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	1869	1878
Inflammation	175	176
Swelling/ Edema	132	132
Insufficient Information	130	133
Erythema	124	125
Fluid Discharge	98	99
Unspecified Infection	96	96
Pain	94	95
Hemorrhage/Bleeding	88	88
Purulent Discharge	65	65
Skin Inflammation/ Irritation	49	49
Wound Dehiscence	47	47
Itching Sensation	46	46
Hypersensitivity/Allergic reaction	45	45
Impaired Healing	36	36
Pocket Erosion	23	23
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
Abscess	10	10
Discomfort	10	10
Hematoma	7	7
Hernia	6	6
Unintended Radiation Exposure	5	5
Ulcer	5	5
Failure to Anastomose	5	5
Seroma	5	5
Fistula	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Eye Injury	4	4
Obstruction/Occlusion	4	4
Burning Sensation	4	4
Corneal Edema	3	3
Scar Tissue	3	3
Nerve Damage	3	3
Thrombosis/Thrombus	3	3
Needle Stick/Puncture	3	3
Chills	3	3
Pneumothorax	3	3
Intraocular Pressure Increased	3	3
Cyst(s)	3	3
Adhesion(s)	3	3
Visual Disturbances	2	2
Urinary Retention	2	2
Numbness	2	2