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	1
FEELTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOOSIN MEDICAL SUPPLIES INC., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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	5172	5906
Material Separation	2358	2358
Adverse Event Without Identified Device or Use Problem	1505	6744
Positioning Failure	355	355
Material Integrity Problem	320	320
Detachment of Device or Device Component	146	390
Patient Device Interaction Problem	119	241
Defective Component	100	100
Material Frayed	95	95
Migration	72	72
Device Markings/Labelling Problem	58	58
Delivered as Unsterile Product	54	54
Component Misassembled	44	44
Material Twisted/Bent	41	163
Separation Problem	39	39
Material Split, Cut or Torn	34	34
Material Protrusion/Extrusion	34	156
Device Contaminated During Manufacture or Shipping	33	33
Appropriate Term/Code Not Available	22	22
Positioning Problem	22	22
Migration or Expulsion of Device	20	20
Difficult to Open or Remove Packaging Material	20	20
Manufacturing, Packaging or Shipping Problem	19	19
Tear, Rip or Hole in Device Packaging	15	15
Device Appears to Trigger Rejection	14	14
Expulsion	12	12
Material Fragmentation	10	10
Component Missing	10	10
Product Quality Problem	9	9
Insufficient Information	8	8
Packaging Problem	8	8
Dull, Blunt	7	7
Material Deformation	7	7
No Apparent Adverse Event	6	6
Use of Device Problem	6	6
Material Discolored	6	6
Device Fell	6	6
Difficult or Delayed Positioning	5	5
Inadequacy of Device Shape and/or Size	4	4
Patient-Device Incompatibility	4	4
Separation Failure	4	4
Entrapment of Device	4	4
Material Rupture	3	3
Incomplete or Missing Packaging	3	3
Degraded	2	2
Crack	2	2
Missing Information	2	2
Nonstandard Device	2	2
Loose or Intermittent Connection	2	2
Device Slipped	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7263	7753
Wound Dehiscence	759	2002
No Consequences Or Impact To Patient	678	678
Unspecified Infection	463	585
Insufficient Information	348	470
Pain	209	209
Hemorrhage/Bleeding	166	166
Foreign Body In Patient	133	377
Hernia	132	132
Inflammation	127	127
Failure to Anastomose	121	121
Impaired Healing	118	240
Post Operative Wound Infection	114	4232
Hematoma	111	111
Abscess	105	105
Fistula	94	94
Pocket Erosion	93	93
Obstruction/Occlusion	85	85
Seroma	83	1082
Erythema	81	81
Swelling/ Edema	80	80
Not Applicable	80	80
Fluid Discharge	80	202
Necrosis	75	1074
Unspecified Tissue Injury	73	73
Discomfort	68	68
Hypersensitivity/Allergic reaction	59	59
Purulent Discharge	58	58
Skin Inflammation/ Irritation	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	50	4168
Granuloma	49	49
Fever	48	48
Nodule	43	43
Scar Tissue	40	40
Sepsis	33	33
No Code Available	29	29
Foreign Body Reaction	29	29
Local Reaction	28	28
Urinary Tract Infection	28	28
Incontinence	25	25
Itching Sensation	24	24
Joint Dislocation	23	23
Rupture	20	20
Ulcer	19	19
Blood Loss	18	18
Cellulitis	18	18
No Known Impact Or Consequence To Patient	17	17
Adhesion(s)	16	16
Thrombosis/Thrombus	16	16
Pneumonia	14	14