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
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	1
PDO MAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUTURION AB
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4777	5509
Material Separation	2155	2155
Adverse Event Without Identified Device or Use Problem	1382	2625
Positioning Failure	311	311
Material Integrity Problem	303	303
Detachment of Device or Device Component	134	378
Patient Device Interaction Problem	116	238
Defective Component	86	86
Material Frayed	84	84
Migration	71	71
Device Markings/Labelling Problem	53	53
Delivered as Unsterile Product	46	46
Component Misassembled	44	44
Material Twisted/Bent	39	161
Material Protrusion/Extrusion	34	156
Material Split, Cut or Torn	33	33
Separation Problem	31	31
Device Contaminated During Manufacture or Shipping	28	28
Positioning Problem	22	22
Appropriate Term/Code Not Available	20	20
Migration or Expulsion of Device	20	20
Manufacturing, Packaging or Shipping Problem	19	19
Difficult to Open or Remove Packaging Material	19	19
Tear, Rip or Hole in Device Packaging	15	15
Device Appears to Trigger Rejection	14	14
Expulsion	12	12
Component Missing	9	9
Product Quality Problem	8	8
Packaging Problem	8	8
Insufficient Information	7	7
Dull, Blunt	7	7
Device Fell	6	6
Material Fragmentation	6	6
Material Discolored	6	6
Material Deformation	6	6
Difficult or Delayed Positioning	5	5
Patient-Device Incompatibility	4	4
Separation Failure	4	4
Inadequacy of Device Shape and/or Size	4	4
Entrapment of Device	4	4
Use of Device Problem	4	4
Nonstandard Device	2	2
Loose or Intermittent Connection	2	2
Material Rupture	2	2
Degraded	2	2
Crack	2	2
Incomplete or Missing Packaging	2	2
Device Slipped	2	2
Difficult or Delayed Separation	1	1
Dent in Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6611	7099
Wound Dehiscence	710	1953
No Consequences Or Impact To Patient	678	678
Unspecified Infection	428	550
Insufficient Information	317	439
Pain	197	197
Hemorrhage/Bleeding	160	160
Hernia	125	125
Inflammation	111	111
Foreign Body In Patient	111	355
Failure to Anastomose	105	105
Hematoma	104	104
Post Operative Wound Infection	103	225
Abscess	101	101
Impaired Healing	95	217
Fistula	89	89
Pocket Erosion	85	85
Obstruction/Occlusion	81	81
Not Applicable	80	80
Fluid Discharge	78	200
Swelling/ Edema	75	75
Seroma	73	1072
Erythema	70	70
Unspecified Tissue Injury	68	68
Necrosis	67	1066
Discomfort	64	64
Purulent Discharge	57	57
Hypersensitivity/Allergic reaction	54	54
Skin Inflammation/ Irritation	53	53
Granuloma	45	45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	45	167
Nodule	42	42
Scar Tissue	35	35
Fever	34	34
Sepsis	33	33
No Code Available	29	29
Urinary Tract Infection	28	28
Foreign Body Reaction	28	28
Incontinence	25	25
Local Reaction	25	25
Itching Sensation	24	24
Joint Dislocation	21	21
Rupture	20	20
Ulcer	19	19
Cellulitis	18	18
Blood Loss	18	18
No Known Impact Or Consequence To Patient	17	17
Thrombosis/Thrombus	15	15
Adhesion(s)	13	13
Urinary Retention	13	13