TPLC - Total Product Life Cycle

show TPLC since

Device	suture, nonabsorbable, synthetic, polypropylene
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
SILHOUETTE LIFT INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5063	5185
Material Separation	3328	4035
Adverse Event Without Identified Device or Use Problem	1079	1079
Detachment of Device or Device Component	672	672
Material Frayed	399	399
Material Split, Cut or Torn	152	152
Material Integrity Problem	139	139
Material Twisted/Bent	60	60
Device Markings/Labelling Problem	55	55
Device Contaminated During Manufacture or Shipping	41	41
Component Misassembled	39	39
Delivered as Unsterile Product	39	39
Dull, Blunt	38	38
Defective Component	35	35
Unraveled Material	34	34
Insufficient Information	29	29
Mechanical Problem	21	21
Manufacturing, Packaging or Shipping Problem	19	19
Positioning Failure	19	19
Appropriate Term/Code Not Available	18	18
Product Quality Problem	15	15
Tear, Rip or Hole in Device Packaging	14	14
Packaging Problem	12	12
Component Missing	11	11
Separation Problem	10	10
Off-Label Use	10	10
Patient-Device Incompatibility	9	9
Component Incompatible	7	7
Difficult to Open or Remove Packaging Material	6	6
Fracture	6	6
Migration	6	6
Material Deformation	6	6
Material Rupture	6	6
Separation Failure	5	5
Patient Device Interaction Problem	5	5
Material Fragmentation	5	5
Improper or Incorrect Procedure or Method	4	4
Use of Device Problem	4	4
Material Discolored	4	4
Contamination /Decontamination Problem	4	4
Unsealed Device Packaging	4	4
Inadequacy of Device Shape and/or Size	3	3
Human-Device Interface Problem	3	3
Device Slipped	3	3
Loss of or Failure to Bond	3	3
Degraded	2	2
Microbial Contamination of Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	2	2
Disconnection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6214	6336
No Consequences Or Impact To Patient	2458	3165
Insufficient Information	517	517
Unspecified Infection	237	237
Hemorrhage/Bleeding	229	229
No Known Impact Or Consequence To Patient	216	216
Not Applicable	199	199
Pain	163	163
Wound Dehiscence	148	148
Fistula	105	105
Hematoma	103	103
Hernia	93	93
Post Operative Wound Infection	91	91
Seroma	87	87
No Code Available	81	81
Foreign Body In Patient	78	78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	75	75
Failure to Anastomose	74	74
Blood Loss	67	67
Unspecified Tissue Injury	66	66
Unintended Radiation Exposure	54	54
Obstruction/Occlusion	53	53
Swelling/ Edema	43	43
Abscess	43	43
No Information	41	41
Inflammation	39	39
Necrosis	39	39
No Patient Involvement	37	37
Thrombosis/Thrombus	33	33
Fever	31	31
Sepsis	28	28
Scar Tissue	28	28
Incontinence	27	27
Fluid Discharge	25	25
Impaired Healing	25	25
Erosion	25	25
Stenosis	24	24
Urinary Retention	24	24
Granuloma	23	23
Cerebrospinal Fluid Leakage	22	22
Erythema	20	20
Discomfort	19	19
Visual Impairment	19	19
Urinary Tract Infection	18	18
Ischemia	17	17
Device Embedded In Tissue or Plaque	17	17
Adhesion(s)	15	15
Paresis	14	14
Pleural Effusion	14	14
Myocardial Infarction	13	13

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien, LP	II	Feb-25-2023