TPLC - Total Product Life Cycle

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Device	suture, surgical, absorbable, polydioxanone
Regulation Description	Absorbable polydioxanone surgical suture.
Product Code	NEW
Regulation Number	878.4840
Device Class	2

Premarket Reviews
Manufacturer	Decision
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	3
FEELTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HYUNDAE MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
M/S. MERIL ENDO SURGERY PRIVATE LIMITED.
	SUBSTANTIALLY EQUIVALENT	2
PDO MAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUTURION AB
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5251	7993
Material Separation	2554	2556
Adverse Event Without Identified Device or Use Problem	1601	2886
Positioning Failure	433	433
Material Integrity Problem	342	342
Detachment of Device or Device Component	148	394
Patient Device Interaction Problem	119	241
Material Frayed	100	100
Defective Component	99	99
Device Markings/Labelling Problem	70	70
Migration	69	69
Delivered as Unsterile Product	62	62
Component Misassembled	47	47
Material Twisted/Bent	47	169
Separation Problem	45	45
Device Contaminated During Manufacture or Shipping	44	44
Material Split, Cut or Torn	39	39
Material Protrusion/Extrusion	34	156
Migration or Expulsion of Device	20	20
Difficult to Open or Remove Packaging Material	20	20
Manufacturing, Packaging or Shipping Problem	19	19
Product Quality Problem	18	18
Device Appears to Trigger Rejection	14	14
Appropriate Term/Code Not Available	14	14
Insufficient Information	14	14
Tear, Rip or Hole in Device Packaging	13	13
Expulsion	12	12
Packaging Problem	12	12
Material Fragmentation	11	11
Material Discolored	10	10
Dull, Blunt	9	9
Component Missing	9	9
Material Deformation	8	8
Use of Device Problem	7	7
No Apparent Adverse Event	6	6
Difficult or Delayed Positioning	5	5
Device Fell	5	5
Patient-Device Incompatibility	4	4
Separation Failure	4	4
Entrapment of Device	4	4
Material Rupture	3	3
Material Disintegration	2	2
Crack	2	2
Missing Information	2	2
Nonstandard Device	2	2
Improper or Incorrect Procedure or Method	2	2
Mechanical Jam	2	2
Device Slipped	2	2
Dent in Material	1	1
Fail-Safe Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8210	8710
Wound Dehiscence	816	1072
Unspecified Infection	499	623
Insufficient Information	427	550
Pain	211	212
Hemorrhage/Bleeding	204	206
Foreign Body In Patient	150	395
Hernia	146	146
Failure to Anastomose	137	137
Impaired Healing	128	250
Hematoma	126	126
Inflammation	124	124
Post Operative Wound Infection	115	1266
Pocket Erosion	114	114
Obstruction/Occlusion	104	105
Seroma	104	115
Fistula	101	101
Abscess	97	97
Necrosis	90	101
Swelling/ Edema	86	87
Fluid Discharge	83	205
Unspecified Tissue Injury	83	83
Erythema	80	80
Discomfort	72	72
Purulent Discharge	66	66
Granuloma	58	58
Hypersensitivity/Allergic reaction	57	57
Skin Inflammation/ Irritation	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	53	3213
Fever	46	46
Nodule	45	45
Scar Tissue	41	41
Sepsis	29	30
Local Reaction	28	28
Incontinence	26	26
Urinary Tract Infection	25	25
Joint Dislocation	24	24
Itching Sensation	24	24
Adhesion(s)	21	21
Rupture	20	20
Foreign Body Reaction	20	20
Ulcer	18	18
Thrombosis/Thrombus	17	17
Ischemia	15	15
Pneumonia	14	14
Blister	14	14
Pleural Effusion	13	13
Urinary Retention	13	13
Paresis	13	13
Cellulitis	13	13