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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 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1308 1308
Material Separation 690 690
Adverse Event Without Identified Device or Use Problem 282 282
Detachment of Device or Device Component 174 174
Material Split, Cut or Torn 70 70
Component Misassembled 49 49
Dull, Blunt 46 46
Manufacturing, Packaging or Shipping Problem 43 43
Material Integrity Problem 40 40
Defective Component 36 36
Device Markings/Labelling Problem 36 36
Appropriate Term/Code Not Available 30 30
Product Quality Problem 24 24
Delivered as Unsterile Product 21 21
Material Discolored 15 15
Positioning Failure 14 14
Packaging Problem 14 14
Material Twisted/Bent 9 9
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
Device Contaminated During Manufacture or Shipping 6 6
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
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
Missing Information 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1564 1564
No Consequences Or Impact To Patient 701 701
Insufficient Information 117 117
Unspecified Infection 106 106
No Known Impact Or Consequence To Patient 61 61
Wound Dehiscence 55 55
Hemorrhage/Bleeding 37 37
Post Operative Wound Infection 37 37
Thrombosis/Thrombus 36 36
Pain 30 30
Cerebrospinal Fluid Leakage 22 22
Foreign Body In Patient 22 22
Hematoma 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Not Applicable 17 17
Inflammation 16 16
No Patient Involvement 15 15
Swelling/ Edema 14 14
Necrosis 14 14
No Information 13 13
No Code Available 11 11
Unspecified Tissue Injury 11 11
Fluid Discharge 10 10
Impaired Healing 10 10
Scar Tissue 10 10
Seroma 10 10
Abscess 10 10
Erythema 10 10
Unintended Radiation Exposure 9 9
Radiation Exposure, Unintended 6 6
Skin Irritation 6 6
Discomfort 6 6
Hernia 5 5
Hypersensitivity/Allergic reaction 5 5
Granuloma 5 5
Meningitis 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
Visual Disturbances 4 4
Sepsis 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
Burning Sensation 2 2
Tissue Damage 2 2
Visual Impairment 2 2
Loss of Vision 2 2
Vitreous Loss 1 1
Vomiting 1 1
Weakness 1 1
Hypoesthesia 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Ulcer 1 1
Distress 1 1
Rupture 1 1
Convulsion, Tonic 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
Eye Pain 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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