TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
DEMETECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	3
FOOSIN MEDICAL SUPPLIES INC., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
HYUNDAE MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDITIME CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PDO MAX, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4596	5328
Material Separation	1783	1783
Adverse Event Without Identified Device or Use Problem	1148	1392
Material Integrity Problem	282	282
Positioning Failure	203	203
Detachment of Device or Device Component	124	368
Patient Device Interaction Problem	108	230
Material Frayed	70	70
Migration	68	68
Defective Component	59	59
Positioning Problem	52	52
Device Markings/Labelling Problem	45	45
Component Misassembled	42	42
Appropriate Term/Code Not Available	40	40
Material Protrusion/Extrusion	35	157
Tear, Rip or Hole in Device Packaging	34	34
Material Split, Cut or Torn	33	33
Material Twisted/Bent	30	152
Migration or Expulsion of Device	25	25
Delivered as Unsterile Product	25	25
Device Contaminated During Manufacture or Shipping	20	20
Difficult to Open or Remove Packaging Material	19	19
Separation Problem	18	18
Manufacturing, Packaging or Shipping Problem	18	18
Device Appears to Trigger Rejection	12	12
Expulsion	12	12
Component Missing	10	10
Material Fragmentation	7	7
Device Fell	7	7
Inadequacy of Device Shape and/or Size	7	7
Material Discolored	6	6
Packaging Problem	6	6
Patient-Device Incompatibility	6	6
Entrapment of Device	6	6
Component Incompatible	6	6
Insufficient Information	5	5
Degraded	5	5
Difficult or Delayed Positioning	5	5
Material Deformation	4	4
Loss of or Failure to Bond	4	4
Dull, Blunt	4	4
Use of Device Problem	3	3
Product Quality Problem	3	3
Loose or Intermittent Connection	3	3
Unsealed Device Packaging	2	2
Separation Failure	2	2
Difficult to Remove	2	2
Material Rupture	2	2
Crack	2	2
Incomplete or Missing Packaging	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5039	5527
No Consequences Or Impact To Patient	1572	1572
Wound Dehiscence	538	782
Unspecified Infection	348	470
Insufficient Information	224	346
Not Applicable	193	193
Pain	191	191
Hemorrhage/Bleeding	117	117
Hernia	105	105
Inflammation	104	104
Hematoma	98	98
Abscess	90	90
Failure to Anastomose	87	87
Foreign Body In Patient	83	327
Post Operative Wound Infection	80	202
Fistula	80	80
Impaired Healing	74	196
Obstruction/Occlusion	65	65
Seroma	64	64
Discomfort	64	64
No Code Available	63	63
Fluid Discharge	61	183
Erythema	60	60
Pocket Erosion	58	58
Unspecified Tissue Injury	58	58
Swelling/ Edema	56	56
Purulent Discharge	53	53
Necrosis	48	48
Skin Inflammation/ Irritation	45	45
Hypersensitivity/Allergic reaction	45	45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	165
No Known Impact Or Consequence To Patient	40	40
Fever	39	39
Scar Tissue	37	37
Nodule	34	34
Foreign Body Reaction	34	34
Sepsis	30	30
Blood Loss	28	28
Joint Dislocation	25	25
Granuloma	24	24
Urinary Tract Infection	23	23
Itching Sensation	23	23
Incontinence	21	21
Rupture	20	20
Ulcer	19	19
Local Reaction	18	18
Swelling	16	16
Cellulitis	15	15
Adhesion(s)	13	13
Thrombosis/Thrombus	12	12