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
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	1413	1423
Material Separation	828	829
Adverse Event Without Identified Device or Use Problem	320	320
Detachment of Device or Device Component	206	207
Material Split, Cut or Torn	106	106
Dull, Blunt	86	86
Defective Component	60	60
Device Contaminated During Manufacture or Shipping	54	54
Component Misassembled	51	51
Product Quality Problem	48	48
Manufacturing, Packaging or Shipping Problem	40	41
Delivered as Unsterile Product	34	35
Device Markings/Labelling Problem	31	31
Material Frayed	23	23
Material Discolored	23	23
Appropriate Term/Code Not Available	18	18
Material Twisted/Bent	16	16
Positioning Failure	14	14
Insufficient Information	10	10
Material Integrity Problem	7	7
Component Missing	7	7
Nonstandard Device	5	5
Unexpected Color	5	5
Packaging Problem	4	4
Crack	4	4
Difficult to Open or Remove Packaging Material	4	4
Material Too Soft/Flexible	4	4
No Apparent Adverse Event	3	3
Patient Device Interaction Problem	2	2
Difficult to Remove	2	2
Patient-Device Incompatibility	2	2
Missing Information	2	2
Device Appears to Trigger Rejection	2	2
Unraveled Material	1	1
Material Fragmentation	1	1
Material Deformation	1	1
Unsealed Device Packaging	1	1
Wrong Label	1	1
Illegible Information	1	1
Mechanical Problem	1	1
Separation Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2616	2628
Insufficient Information	248	249
Unspecified Infection	109	109
Wound Dehiscence	70	70
Hemorrhage/Bleeding	44	44
Thrombosis/Thrombus	37	37
Post Operative Wound Infection	32	32
Foreign Body In Patient	31	31
Pain	28	28
Swelling/ Edema	25	25
Hematoma	25	25
Cerebrospinal Fluid Leakage	22	22
Necrosis	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Seroma	18	18
Impaired Healing	17	17
Fluid Discharge	15	15
Inflammation	13	13
Scar Tissue	12	12
Erythema	11	11
Abscess	10	10
Unspecified Tissue Injury	10	10
Skin Inflammation/ Irritation	9	9
Unintended Radiation Exposure	8	8
Discomfort	7	7
Visual Disturbances	7	7
Hyperemia	6	6
Hyphema	5	5
Meningitis	5	5
Granuloma	5	5
Fever	5	5
Hypersensitivity/Allergic reaction	5	5
Eye Injury	4	4
Corneal Edema	4	4
Red Eye(s)	4	4
Failure to Anastomose	4	4
Numbness	4	4
Foreign Body Reaction	4	4
Hernia	4	4
Nodule	3	3
Headache	3	3
Laceration(s)	3	3
Nerve Damage	3	3
Fistula	3	3
Conjunctivitis	3	3
Hearing Impairment	3	3
Paralysis	3	3
Obstruction/Occlusion	3	3
Intraocular Pressure Increased	3	3
Itching Sensation	3	3