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	2
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	4861	5605
Material Separation	2321	2323
Adverse Event Without Identified Device or Use Problem	1475	6715
Positioning Failure	375	375
Material Integrity Problem	316	316
Detachment of Device or Device Component	134	380
Patient Device Interaction Problem	119	241
Defective Component	99	99
Material Frayed	96	96
Migration	69	69
Device Markings/Labelling Problem	67	67
Delivered as Unsterile Product	61	61
Component Misassembled	42	42
Separation Problem	41	41
Material Twisted/Bent	41	163
Device Contaminated During Manufacture or Shipping	36	36
Material Protrusion/Extrusion	34	156
Material Split, Cut or Torn	31	31
Migration or Expulsion of Device	20	20
Difficult to Open or Remove Packaging Material	20	20
Manufacturing, Packaging or Shipping Problem	19	19
Device Appears to Trigger Rejection	14	14
Appropriate Term/Code Not Available	14	14
Tear, Rip or Hole in Device Packaging	13	13
Expulsion	12	12
Product Quality Problem	12	12
Insufficient Information	11	11
Packaging Problem	11	11
Material Fragmentation	10	10
Material Discolored	10	10
Dull, Blunt	8	8
Component Missing	8	8
Material Deformation	7	7
No Apparent Adverse Event	6	6
Use of Device Problem	6	6
Device Fell	5	5
Difficult or Delayed Positioning	5	5
Patient-Device Incompatibility	4	4
Separation Failure	4	4
Material Rupture	3	3
Entrapment of Device	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	7557	8057
Wound Dehiscence	745	1989
Unspecified Infection	458	582
Insufficient Information	385	508
Pain	198	199
Hemorrhage/Bleeding	187	189
Failure to Anastomose	132	132
Hernia	129	129
Foreign Body In Patient	128	373
Inflammation	120	120
Impaired Healing	117	239
Hematoma	109	109
Post Operative Wound Infection	106	4224
Pocket Erosion	96	96
Abscess	96	96
Fistula	95	95
Obstruction/Occlusion	92	93
Seroma	89	1088
Swelling/ Edema	81	82
Necrosis	80	1079
Unspecified Tissue Injury	79	79
Fluid Discharge	76	198
Erythema	75	75
Discomfort	72	72
Skin Inflammation/ Irritation	57	57
Hypersensitivity/Allergic reaction	57	57
Purulent Discharge	56	56
Granuloma	52	52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	51	5168
Nodule	45	45
Fever	45	45
Scar Tissue	38	38
Sepsis	28	29
Local Reaction	28	28
Urinary Tract Infection	25	25
Incontinence	25	25
Joint Dislocation	24	24
Itching Sensation	24	24
Foreign Body Reaction	20	20
Rupture	20	20
Ulcer	18	18
Adhesion(s)	18	18
Thrombosis/Thrombus	16	16
Cellulitis	13	13
Pleural Effusion	13	13
Paresis	13	13
Ischemia	13	13
Pneumonia	13	13
Blister	12	12
Urinary Retention	12	12