TPLC - Total Product Life Cycle

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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
APTOS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
CYPRIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
LYDUS MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
MSI
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4538	4660
Material Separation	2779	2779
Adverse Event Without Identified Device or Use Problem	1082	1082
Detachment of Device or Device Component	549	549
Material Frayed	355	355
Material Split, Cut or Torn	141	141
Material Twisted/Bent	61	61
Device Markings/Labelling Problem	53	53
Component Misassembled	47	47
Device Contaminated During Manufacture or Shipping	44	44
Material Integrity Problem	44	44
Delivered as Unsterile Product	39	39
Defective Component	35	35
Dull, Blunt	32	32
Insufficient Information	29	29
Unraveled Material	20	20
Manufacturing, Packaging or Shipping Problem	19	19
Positioning Failure	19	19
Appropriate Term/Code Not Available	15	15
Product Quality Problem	12	12
Component Missing	11	11
Off-Label Use	9	9
Patient-Device Incompatibility	9	9
Packaging Problem	9	9
Fracture	6	6
Difficult to Open or Remove Packaging Material	6	6
Migration	6	6
Separation Failure	5	5
Tear, Rip or Hole in Device Packaging	5	5
Improper or Incorrect Procedure or Method	4	4
Material Deformation	4	4
Use of Device Problem	4	4
Material Discolored	4	4
Patient Device Interaction Problem	4	4
Separation Problem	4	4
Material Rupture	3	3
Unsealed Device Packaging	3	3
Human-Device Interface Problem	3	3
Loss of or Failure to Bond	3	3
Contamination /Decontamination Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Mechanical Problem	2	2
Device Slipped	2	2
Disconnection	2	2
Material Fragmentation	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Dent in Material	1	1
Microbial Contamination of Device	1	1
Mechanics Altered	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6651	6773
No Consequences Or Impact To Patient	1042	1042
Insufficient Information	605	605
Hemorrhage/Bleeding	248	248
Unspecified Infection	240	240
Wound Dehiscence	144	144
Pain	137	137
Not Applicable	126	126
Fistula	108	108
Hematoma	90	90
Hernia	85	85
Post Operative Wound Infection	82	82
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	76	76
Failure to Anastomose	76	76
Foreign Body In Patient	75	75
Seroma	68	68
Unspecified Tissue Injury	68	68
Unintended Radiation Exposure	55	55
Swelling/ Edema	54	54
Obstruction/Occlusion	53	53
No Known Impact Or Consequence To Patient	49	49
No Code Available	47	47
Inflammation	41	41
Abscess	40	40
Necrosis	39	39
Thrombosis/Thrombus	35	35
Fever	32	32
Scar Tissue	28	28
Sepsis	27	27
Granuloma	26	26
Cerebrospinal Fluid Leakage	26	26
Impaired Healing	26	26
Blood Loss	25	25
Fluid Discharge	25	25
Incontinence	24	24
Urinary Retention	24	24
Stenosis	24	24
Erosion	22	22
Erythema	20	20
Ischemia	19	19
Urinary Tract Infection	18	18
Visual Impairment	17	17
Discomfort	16	16
Eye Injury	15	15
Adhesion(s)	15	15
Hyphema	15	15
Pocket Erosion	15	15
Pleural Effusion	14	14
Intraocular Pressure Increased	14	14
Purulent Discharge	14	14