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	1288	1288
Adverse Event Without Identified Device or Use Problem	365	365
Material Separation	267	267
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	32	32
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
Patient-Device Incompatibility	5	5
Defective Device	5	5
Component Missing	5	5
Material Twisted/Bent	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
Device Damaged Prior to Use	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	1537	1537
No Consequences Or Impact To Patient	232	232
Inflammation	182	182
Erythema	133	133
Swelling/ Edema	103	103
Insufficient Information	97	97
Unspecified Infection	94	94
Pain	93	93
Fluid Discharge	91	91
Hemorrhage/Bleeding	76	76
Purulent Discharge	51	51
Wound Dehiscence	50	50
Skin Inflammation/ Irritation	46	46
Itching Sensation	42	42
Hypersensitivity/Allergic reaction	39	39
Impaired Healing	35	35
No Known Impact Or Consequence To Patient	32	32
Not Applicable	32	32
Post Operative Wound Infection	21	21
Pocket Erosion	19	19
Foreign Body In Patient	13	13
Fistula	12	12
Fever	11	11
Foreign Body Reaction	11	11
Local Reaction	11	11
Necrosis	11	11
Abscess	10	10
Granuloma	10	10
Unspecified Tissue Injury	9	9
Discomfort	8	8
No Information	8	8
No Code Available	8	8
Failure to Anastomose	7	7
Blood Loss	7	7
Unintended Radiation Exposure	6	6
Scar Tissue	5	5
Obstruction/Occlusion	4	4
Ulcer	4	4
Hernia	4	4
Pneumothorax	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Burning Sensation	4	4
Eye Injury	3	3
Bacterial Infection	3	3
Thrombosis/Thrombus	3	3
Cyst(s)	3	3
Sepsis	3	3
Needle Stick/Puncture	2	2
Ptosis	2	2
Chills	2	2