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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1265 1265
Material Separation 635 635
Adverse Event Without Identified Device or Use Problem 276 276
Detachment of Device or Device Component 170 170
Material Split, Cut or Torn 70 70
Component Misassembled 47 47
Manufacturing, Packaging or Shipping Problem 42 42
Material Integrity Problem 40 40
Dull, Blunt 39 39
Device Markings/Labelling Problem 36 36
Appropriate Term/Code Not Available 30 30
Product Quality Problem 24 24
Defective Component 22 22
Delivered as Unsterile Product 21 21
Positioning Failure 14 14
Packaging Problem 14 14
Material Discolored 13 13
Material Twisted/Bent 9 9
Component Incompatible 8 8
Inadequacy of Device Shape and/or Size 8 8
Component Missing 7 7
Insufficient Information 7 7
Patient-Device Incompatibility 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
Unsealed Device Packaging 2 2
Crack 2 2
Material Fragmentation 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination /Decontamination Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Patient Device Interaction Problem 2 2
Material Deformation 2 2
Mechanical Jam 1 1
Loss of or Failure to Bond 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Material Rupture 1 1
Unraveled Material 1 1
Use of Device Problem 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 1451 1451
No Consequences Or Impact To Patient 701 701
Insufficient Information 108 108
Unspecified Infection 106 106
No Known Impact Or Consequence To Patient 61 61
Wound Dehiscence 55 55
Hemorrhage/Bleeding 36 36
Thrombosis/Thrombus 36 36
Post Operative Wound Infection 36 36
Pain 30 30
Cerebrospinal Fluid Leakage 21 21
Foreign Body In Patient 21 21
Hematoma 20 20
Not Applicable 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Seroma 10 10
Scar Tissue 9 9
Abscess 9 9
Erythema 9 9
Unintended Radiation Exposure 9 9
Radiation Exposure, Unintended 6 6
Skin Irritation 6 6
Hernia 5 5
Discomfort 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
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
Foreign Body Sensation in Eye 2 2
Failure to Anastomose 2 2
Cyst(s) 2 2
Edema 2 2
Hyphema 2 2
Scarring 2 2
Sepsis 2 2
Local Reaction 2 2
Tissue Damage 2 2
Visual Impairment 2 2
Loss of Vision 2 2
Nausea 2 2
Burning Sensation 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
Incontinence 1 1
Pneumothorax 1 1
Pocket Erosion 1 1
Loss of Range of Motion 1 1
Emotional Changes 1 1
Eye Injury 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
Pulmonary Embolism 1 1
Hemoptysis 1 1
Laceration(s) 1 1
High Blood Pressure/ Hypertension 1 1
Eye Pain 1 1
Spontaneous Abortion 1 1
Unspecified Musculoskeletal problem 1 1
Neck 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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