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	2
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	4681	5413
Material Separation	1843	1843
Adverse Event Without Identified Device or Use Problem	1159	1403
Material Integrity Problem	285	285
Positioning Failure	215	215
Detachment of Device or Device Component	124	368
Patient Device Interaction Problem	108	230
Material Frayed	70	70
Migration	68	68
Defective Component	61	61
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	31	153
Delivered as Unsterile Product	26	26
Migration or Expulsion of Device	25	25
Device Contaminated During Manufacture or Shipping	22	22
Separation Problem	22	22
Difficult to Open or Remove Packaging Material	19	19
Manufacturing, Packaging or Shipping Problem	18	18
Expulsion	12	12
Device Appears to Trigger Rejection	12	12
Component Missing	10	10
Inadequacy of Device Shape and/or Size	7	7
Material Fragmentation	7	7
Device Fell	7	7
Patient-Device Incompatibility	6	6
Packaging Problem	6	6
Material Discolored	6	6
Entrapment of Device	6	6
Component Incompatible	6	6
Degraded	5	5
Difficult or Delayed Positioning	5	5
Insufficient Information	5	5
Material Deformation	4	4
Loss of or Failure to Bond	4	4
Dull, Blunt	4	4
Separation Failure	3	3
Use of Device Problem	3	3
Loose or Intermittent Connection	3	3
Product Quality Problem	3	3
Noise, Audible	2	124
Nonstandard Device	2	2
Crack	2	2
Fracture	2	124
Incomplete or Missing Packaging	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5188	5676
No Consequences Or Impact To Patient	1572	1572
Wound Dehiscence	542	786
Unspecified Infection	353	475
Insufficient Information	227	349
Not Applicable	193	193
Pain	192	192
Hemorrhage/Bleeding	121	121
Hernia	105	105
Inflammation	104	104
Hematoma	98	98
Abscess	91	91
Failure to Anastomose	87	87
Foreign Body In Patient	85	329
Post Operative Wound Infection	82	204
Fistula	80	80
Impaired Healing	74	196
Obstruction/Occlusion	67	67
Seroma	65	65
Discomfort	64	64
No Code Available	63	63
Fluid Discharge	63	185
Erythema	60	60
Unspecified Tissue Injury	59	59
Pocket Erosion	58	58
Swelling/ Edema	56	56
Purulent Discharge	54	54
Necrosis	48	48
Skin Inflammation/ Irritation	46	46
Hypersensitivity/Allergic reaction	45	45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	166
No Known Impact Or Consequence To Patient	40	40
Fever	39	39
Scar Tissue	38	38
Nodule	34	34
Foreign Body Reaction	34	34
Sepsis	30	30
Blood Loss	28	28
Joint Dislocation	27	27
Granuloma	24	24
Itching Sensation	23	23
Urinary Tract Infection	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