TPLC - Total Product Life Cycle

show TPLC since

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	1568	1578
Material Separation	952	953
Adverse Event Without Identified Device or Use Problem	347	347
Detachment of Device or Device Component	220	221
Dull, Blunt	122	122
Material Split, Cut or Torn	120	120
Device Contaminated During Manufacture or Shipping	63	63
Defective Component	60	60
Component Misassembled	53	53
Product Quality Problem	50	50
Manufacturing, Packaging or Shipping Problem	40	41
Device Markings/Labelling Problem	36	36
Delivered as Unsterile Product	34	35
Material Frayed	28	28
Material Twisted/Bent	27	27
Material Discolored	23	23
Appropriate Term/Code Not Available	18	18
Positioning Failure	14	14
Insufficient Information	10	10
Material Integrity Problem	8	8
Component Missing	7	7
Crack	6	6
Nonstandard Device	5	5
Packaging Problem	5	5
Unexpected Color	5	5
Material Too Soft/Flexible	4	4
Difficult to Open or Remove Packaging Material	4	4
No Apparent Adverse Event	3	3
Missing Information	3	3
Separation Problem	2	2
Patient Device Interaction Problem	2	2
Patient-Device Incompatibility	2	2
Unsealed Device Packaging	2	2
Device Appears to Trigger Rejection	2	2
Difficult to Remove	2	2
Device Slipped	1	1
Unraveled Material	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Problem	1	1
Material Fragmentation	1	1
Mechanical Jam	1	1
Material Deformation	1	1
Defective Device	1	1
Illegible Information	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2935	2947
Insufficient Information	299	300
Unspecified Infection	123	123
Wound Dehiscence	75	75
Hemorrhage/Bleeding	44	44
Thrombosis/Thrombus	37	37
Foreign Body In Patient	34	34
Pain	33	33
Post Operative Wound Infection	32	32
Swelling/ Edema	30	30
Hematoma	26	26
Cerebrospinal Fluid Leakage	23	23
Necrosis	22	22
Seroma	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Impaired Healing	17	17
Fluid Discharge	15	15
Inflammation	14	14
Scar Tissue	12	12
Erythema	12	12
Unspecified Tissue Injury	10	10
Abscess	10	10
Skin Inflammation/ Irritation	9	9
Unintended Radiation Exposure	8	8
Hyphema	7	7
Discomfort	7	7
Visual Disturbances	7	7
Meningitis	6	6
Hyperemia	6	6
Fever	6	6
Granuloma	5	5
Hypersensitivity/Allergic reaction	5	5
Eye Injury	5	5
Numbness	5	5
Hernia	5	5
Red Eye(s)	4	4
Intraocular Pressure Increased	4	4
Corneal Edema	4	4
Failure to Anastomose	4	4
Foreign Body Reaction	4	4
Paralysis	4	4
Headache	3	3
Nodule	3	3
Pocket Erosion	3	3
Laceration(s)	3	3
Fistula	3	3
Nerve Damage	3	3
Conjunctivitis	3	3
Hearing Impairment	3	3
Obstruction/Occlusion	3	3