TPLC - Total Product Life Cycle

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Device	suture, nonabsorbable, synthetic, polyamide
Regulation Description	Nonabsorbable polyamide surgical suture.
Product Code	GAR
Regulation Number	878.5020
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANTARMA LLC DBA GOLNIT SUTURES
	SUBSTANTIALLY EQUIVALENT	1
KONO SEISAKUSHO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1423	1423
Material Separation	753	753
Adverse Event Without Identified Device or Use Problem	313	313
Detachment of Device or Device Component	199	199
Material Split, Cut or Torn	83	83
Dull, Blunt	62	62
Defective Component	56	56
Component Misassembled	47	47
Manufacturing, Packaging or Shipping Problem	42	42
Device Contaminated During Manufacture or Shipping	41	41
Device Markings/Labelling Problem	38	38
Product Quality Problem	35	35
Delivered as Unsterile Product	32	32
Appropriate Term/Code Not Available	21	21
Material Frayed	21	21
Material Discolored	21	21
Positioning Failure	14	14
Material Twisted/Bent	11	11
Material Integrity Problem	9	9
Insufficient Information	8	8
Component Missing	8	8
Packaging Problem	7	7
Difficult to Open or Remove Packaging Material	5	5
Material Too Soft/Flexible	4	4
Unexpected Color	4	4
Patient-Device Incompatibility	3	3
Inadequacy of Device Shape and/or Size	3	3
Tear, Rip or Hole in Device Packaging	3	3
Patient Device Interaction Problem	2	2
Missing Information	2	2
Nonstandard Device	2	2
Unsealed Device Packaging	2	2
Difficult to Remove	2	2
Contamination /Decontamination Problem	2	2
Mechanical Jam	1	1
Separation Problem	1	1
Wrong Label	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Material Deformation	1	1
Material Fragmentation	1	1
Device Slipped	1	1
Unraveled Material	1	1
Use of Device Problem	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2268	2268
No Consequences Or Impact To Patient	273	273
Insufficient Information	178	178
Unspecified Infection	115	115
Wound Dehiscence	65	65
Hemorrhage/Bleeding	41	41
Thrombosis/Thrombus	37	37
Post Operative Wound Infection	35	35
Foreign Body In Patient	30	30
Pain	29	29
Hematoma	24	24
Cerebrospinal Fluid Leakage	23	23
Necrosis	21	21
Swelling/ Edema	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Seroma	15	15
Fluid Discharge	15	15
No Known Impact Or Consequence To Patient	15	15
Impaired Healing	15	15
Inflammation	14	14
Abscess	14	14
Erythema	12	12
Unspecified Tissue Injury	11	11
Not Applicable	11	11
Scar Tissue	10	10
No Patient Involvement	9	9
Unintended Radiation Exposure	9	9
Hypersensitivity/Allergic reaction	7	7
Skin Inflammation/ Irritation	7	7
Discomfort	6	6
Hernia	6	6
Skin Irritation	6	6
No Information	6	6
Visual Disturbances	6	6
Meningitis	5	5
Granuloma	5	5
Obstruction/Occlusion	4	4
No Code Available	4	4
Sepsis	4	4
Fever	4	4
Fistula	4	4
Foreign Body Reaction	4	4
Headache	4	4
Hyphema	4	4
Failure to Anastomose	3	3
Numbness	3	3
Cellulitis	3	3
Nodule	3	3
Conjunctivitis	3	3
Paralysis	3	3