TPLC - Total Product Life Cycle

show TPLC since

Device	suture, nonabsorbable, synthetic, polypropylene
Regulation Description	Nonabsorbable polypropylene surgical suture.
Product Code	GAW
Regulation Number	878.5010
Device Class	2

Premarket Reviews
Manufacturer	Decision
CYPRIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	1
LYDUS MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MSI
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5357	6493
Material Separation	3175	3184
Adverse Event Without Identified Device or Use Problem	1158	1161
Detachment of Device or Device Component	599	599
Material Frayed	356	356
Material Split, Cut or Torn	260	260
Device Contaminated During Manufacture or Shipping	132	132
Material Twisted/Bent	87	87
Device Markings/Labelling Problem	70	70
Insufficient Information	59	59
Component Misassembled	56	56
Delivered as Unsterile Product	46	46
Defective Component	43	43
Dull, Blunt	37	37
Material Integrity Problem	34	34
Manufacturing, Packaging or Shipping Problem	28	28
Unraveled Material	23	23
Component Missing	20	20
Positioning Failure	20	20
Product Quality Problem	18	18
Device Appears to Trigger Rejection	14	14
Off-Label Use	12	12
Difficult to Open or Remove Packaging Material	12	12
Patient-Device Incompatibility	10	10
Appropriate Term/Code Not Available	9	9
Packaging Problem	8	8
Patient Device Interaction Problem	7	7
Separation Problem	6	6
Nonstandard Device	6	6
Improper or Incorrect Procedure or Method	6	6
Material Discolored	6	6
Fracture	6	6
Fluid/Blood Leak	5	5
Separation Failure	5	5
Material Protrusion/Extrusion	5	5
Material Deformation	4	4
Loss of or Failure to Bond	4	4
Tear, Rip or Hole in Device Packaging	4	4
Use of Device Problem	3	3
Material Rupture	3	3
Device Slipped	3	3
Disconnection	3	3
Human-Device Interface Problem	3	3
No Apparent Adverse Event	3	3
Loose or Intermittent Connection	2	2
Unsealed Device Packaging	2	2
Microbial Contamination of Device	2	2
Device Damaged Prior to Use	1	1
Perivalvular Leak	1	1
Material Puncture/Hole	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8935	9077
Insufficient Information	840	846
Hemorrhage/Bleeding	307	307
Unspecified Infection	259	259
Wound Dehiscence	207	1207
Pain	133	133
Hematoma	100	100
Foreign Body In Patient	99	99
Fistula	97	97
Hernia	94	1093
Seroma	84	84
Failure to Anastomose	84	84
Post Operative Wound Infection	83	83
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	79	1081
Unspecified Tissue Injury	76	76
Swelling/ Edema	71	71
Unintended Radiation Exposure	59	59
Obstruction/Occlusion	56	59
Thrombosis/Thrombus	42	42
Inflammation	42	42
Necrosis	42	42
Abscess	38	38
Impaired Healing	36	36
Scar Tissue	35	35
Fever	31	31
Erythema	30	30
Granuloma	27	27
Urinary Retention	26	26
Stenosis	26	26
Intraocular Pressure Increased	24	24
Cerebrospinal Fluid Leakage	24	24
Hyphema	23	23
Incontinence	22	22
Fluid Discharge	22	22
Erosion	22	22
Sepsis	21	21
Ischemia	21	21
Perforation	21	21
Pocket Erosion	21	21
Eye Injury	17	17
Pneumothorax	16	16
Prolapse	16	16
Adhesion(s)	15	15
Pleural Effusion	15	15
Paresis	14	14
Purulent Discharge	14	14
Urinary Tract Infection	14	14
Discomfort	13	13
Skin Inflammation/ Irritation	13	13
Myocardial Infarction	13	13