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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable, silk
Regulation Description Natural nonabsorbable silk surgical suture.
Product CodeGAP
Regulation Number 878.5030
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
HUAIAN SEAMEN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SAFEPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 426 426
2021 437 437
2022 419 419
2023 404 404
2024 455 455
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1210 1210
Adverse Event Without Identified Device or Use Problem 317 317
Material Separation 254 254
Detachment of Device or Device Component 110 110
Material Split, Cut or Torn 92 92
Delivered as Unsterile Product 43 43
Device Contaminated During Manufacture or Shipping 33 33
Manufacturing, Packaging or Shipping Problem 28 28
Component Misassembled 25 25
Biocompatibility 17 17
Packaging Problem 16 16
Material Frayed 16 16
Device Markings/Labelling Problem 15 15
Nonstandard Device 12 12
Material Integrity Problem 10 10
Defective Component 10 10
Material Discolored 7 7
Product Quality Problem 6 6
Component Missing 5 5
Material Twisted/Bent 5 5
Appropriate Term/Code Not Available 5 5
Patient-Device Incompatibility 5 5
Insufficient Information 4 4
Migration 3 3
Dull, Blunt 3 3
Difficult to Remove 2 2
Use of Device Problem 2 2
Contamination /Decontamination Problem 2 2
Mechanical Problem 2 2
Mechanics Altered 2 2
Difficult to Open or Remove Packaging Material 2 2
Corroded 1 1
Unraveled Material 1 1
Illegible Information 1 1
Device Slipped 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Fracture 1 1
Component Incompatible 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1434 1434
No Consequences Or Impact To Patient 232 232
Inflammation 169 169
Erythema 123 123
Swelling/ Edema 93 93
Unspecified Infection 84 84
Pain 83 83
Fluid Discharge 82 82
Insufficient Information 82 82
Hemorrhage/Bleeding 65 65
Purulent Discharge 45 45
Skin Inflammation/ Irritation 40 40
Wound Dehiscence 40 40
Itching Sensation 34 34
Hypersensitivity/Allergic reaction 33 33
Not Applicable 32 32
No Known Impact Or Consequence To Patient 32 32
Impaired Healing 31 31
Post Operative Wound Infection 19 19
Pocket Erosion 17 17
Foreign Body In Patient 13 13
Foreign Body Reaction 11 11
Fistula 11 11
Granuloma 10 10
Fever 10 10
Unspecified Tissue Injury 9 9
Local Reaction 9 9
Abscess 9 9
No Information 8 8
No Code Available 8 8
Discomfort 7 7
Blood Loss 7 7
Failure to Anastomose 6 6
Necrosis 6 6
Unintended Radiation Exposure 6 6
Scar Tissue 5 5
Ulcer 4 4
Hernia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Bacterial Infection 3 3
Cyst(s) 3 3
Obstruction/Occlusion 3 3
Eye Injury 3 3
Burning Sensation 3 3
Sepsis 3 3
Pneumothorax 3 3
Skin Tears 2 2
Abdominal Distention 2 2
Ptosis 2 2
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP II Jan-29-2024
2 Covidien, LP II Apr-29-2024
3 Covidien, LP II Feb-25-2023
4 Ethicon, Inc. II Jul-02-2020
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