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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, nonabsorbable, synthetic, polyamide
Product CodeGAR
Regulation Number 878.5020
Device Class 2


Premarket Reviews
ManufacturerDecision
ANTARMA LLC DBA GOLNIT SUTURES
  SUBSTANTIALLY EQUIVALENT 1
KONO SEISAKUSHO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 518 518
2020 383 383
2021 532 532
2022 546 546
2023 606 606
2024 262 262

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1339 1339
Material Separation 704 704
Adverse Event Without Identified Device or Use Problem 291 291
Detachment of Device or Device Component 175 175
Material Split, Cut or Torn 73 73
Component Misassembled 49 49
Dull, Blunt 47 47
Manufacturing, Packaging or Shipping Problem 45 45
Material Integrity Problem 40 40
Device Markings/Labelling Problem 39 39
Defective Component 36 36
Appropriate Term/Code Not Available 36 36
Product Quality Problem 28 28
Delivered as Unsterile Product 21 21
Material Discolored 15 15
Positioning Failure 14 14
Packaging Problem 14 14
Device Contaminated During Manufacture or Shipping 12 12
Material Twisted/Bent 10 10
Patient-Device Incompatibility 8 8
Component Incompatible 8 8
Inadequacy of Device Shape and/or Size 8 8
Component Missing 7 7
Insufficient Information 7 7
Tear, Rip or Hole in Device Packaging 5 5
Difficult to Open or Remove Packaging Material 4 4
Difficult to Remove 3 3
Material Frayed 3 3
Mechanical Problem 2 2
Material Fragmentation 2 2
Crack 2 2
Unsealed Device Packaging 2 2
Unraveled Material 2 2
Device Contamination with Chemical or Other Material 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Contamination /Decontamination Problem 2 2
Patient Device Interaction Problem 2 2
Material Deformation 2 2
Missing Information 2 2
Unexpected Color 1 1
Mechanical Jam 1 1
Use of Device Problem 1 1
Device Slipped 1 1
Material Rupture 1 1
Loss of or Failure to Bond 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1627 1627
No Consequences Or Impact To Patient 701 701
Insufficient Information 121 121
Unspecified Infection 107 107
No Known Impact Or Consequence To Patient 61 61
Wound Dehiscence 56 56
Post Operative Wound Infection 38 38
Hemorrhage/Bleeding 37 37
Thrombosis/Thrombus 36 36
Pain 31 31
Foreign Body In Patient 23 23
Cerebrospinal Fluid Leakage 22 22
Hematoma 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Not Applicable 17 17
Inflammation 16 16
Necrosis 15 15
No Patient Involvement 15 15
Swelling/ Edema 14 14
No Information 13 13
Abscess 13 13
Impaired Healing 12 12
No Code Available 11 11
Unspecified Tissue Injury 11 11
Fluid Discharge 10 10
Erythema 10 10
Scar Tissue 10 10
Seroma 10 10
Unintended Radiation Exposure 9 9
Radiation Exposure, Unintended 6 6
Skin Irritation 6 6
Discomfort 6 6
Hypersensitivity/Allergic reaction 5 5
Granuloma 5 5
Meningitis 5 5
Hernia 5 5
Obstruction/Occlusion 4 4
Headache 4 4
Fever 4 4
Fistula 4 4
Foreign Body Reaction 4 4
Purulent Discharge 4 4
Injury 4 4
Sepsis 4 4
Visual Disturbances 4 4
Nerve Damage 3 3
Paralysis 3 3
Conjunctivitis 3 3
Cellulitis 3 3
Hearing Impairment 3 3
Hyperemia 3 3
Numbness 3 3
Skin Inflammation/ Irritation 3 3
Intraocular Pressure Increased 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Nausea 2 2
Foreign Body Sensation in Eye 2 2
Failure to Anastomose 2 2
Cyst(s) 2 2
Eye Injury 2 2
Edema 2 2
Hyphema 2 2
Scarring 2 2
Local Reaction 2 2
Tissue Damage 2 2
Visual Impairment 2 2
Loss of Vision 2 2
Burning Sensation 2 2
Rupture 1 1
Convulsion, Tonic 1 1
Hypoesthesia 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Perforation of Vessels 1 1
Vitreous Loss 1 1
Vomiting 1 1
Weakness 1 1
Respiratory Distress 1 1
Swelling 1 1
Skin Discoloration 1 1
Failure of Implant 1 1
Incontinence 1 1
Pneumothorax 1 1
Pocket Erosion 1 1
Loss of Range of Motion 1 1
Emotional Changes 1 1
Fatigue 1 1
Dyspnea 1 1
Ecchymosis 1 1
Stroke/CVA 1 1
Corneal Edema 1 1
Adult Respiratory Distress Syndrome 1 1
Arthritis 1 1
Pulmonary Embolism 1 1
Hemoptysis 1 1
High Blood Pressure/ Hypertension 1 1
Nodule 1 1
Hydrocephalus 1 1
Ischemia Stroke 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP II Jan-29-2024
2 Covidien, LP II Feb-25-2023
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