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
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4246	4978
Material Separation	1775	1775
Adverse Event Without Identified Device or Use Problem	1158	1402
Material Integrity Problem	275	275
Positioning Failure	234	234
Detachment of Device or Device Component	120	364
Patient Device Interaction Problem	115	237
Migration	68	68
Defective Component	66	66
Material Frayed	64	64
Component Misassembled	43	43
Device Markings/Labelling Problem	43	43
Material Twisted/Bent	37	159
Material Protrusion/Extrusion	34	156
Material Split, Cut or Torn	31	31
Delivered as Unsterile Product	31	31
Separation Problem	28	28
Device Contaminated During Manufacture or Shipping	24	24
Positioning Problem	22	22
Migration or Expulsion of Device	20	20
Appropriate Term/Code Not Available	18	18
Difficult to Open or Remove Packaging Material	18	18
Manufacturing, Packaging or Shipping Problem	18	18
Tear, Rip or Hole in Device Packaging	15	15
Device Appears to Trigger Rejection	13	13
Expulsion	12	12
Component Missing	9	9
Packaging Problem	7	7
Dull, Blunt	7	7
Material Fragmentation	6	6
Device Fell	6	6
Material Discolored	6	6
Insufficient Information	6	6
Difficult or Delayed Positioning	5	5
Patient-Device Incompatibility	4	4
Material Deformation	4	4
Inadequacy of Device Shape and/or Size	4	4
Entrapment of Device	4	4
Use of Device Problem	3	3
Product Quality Problem	3	3
Separation Failure	3	3
Degraded	2	2
Material Rupture	2	2
Crack	2	2
Incomplete or Missing Packaging	2	2
Device Slipped	2	2
Loose or Intermittent Connection	2	2
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Remove	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5646	6134
No Consequences Or Impact To Patient	678	678
Wound Dehiscence	557	801
Unspecified Infection	368	490
Insufficient Information	260	382
Pain	173	173
Hemorrhage/Bleeding	135	135
Hernia	107	107
Inflammation	99	99
Failure to Anastomose	92	92
Hematoma	89	89
Foreign Body In Patient	88	332
Fistula	86	86
Abscess	84	84
Post Operative Wound Infection	81	203
Not Applicable	80	80
Impaired Healing	77	199
Obstruction/Occlusion	67	67
Fluid Discharge	66	188
Swelling/ Edema	65	65
Necrosis	64	64
Discomfort	63	63
Unspecified Tissue Injury	63	63
Erythema	60	60
Seroma	60	60
Pocket Erosion	58	58
Purulent Discharge	55	55
Hypersensitivity/Allergic reaction	50	50
Skin Inflammation/ Irritation	49	49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	45	167
Nodule	41	41
Scar Tissue	35	35
Fever	33	33
Sepsis	30	30
No Code Available	29	29
Granuloma	28	28
Foreign Body Reaction	24	24
Urinary Tract Infection	23	23
Itching Sensation	23	23
Joint Dislocation	21	21
Incontinence	20	20
Rupture	20	20
Ulcer	19	19
Blood Loss	18	18
No Known Impact Or Consequence To Patient	17	17
Cellulitis	15	15
Local Reaction	15	15
Thrombosis/Thrombus	13	13
Swelling	12	12
Urinary Retention	12	12