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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
Product CodeGAP
Regulation Number 878.5030
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 333 333
2020 426 426
2021 437 437
2022 419 419
2023 404 404
2024 116 116

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1191 1191
Adverse Event Without Identified Device or Use Problem 319 319
Material Separation 242 242
Detachment of Device or Device Component 119 119
Material Split, Cut or Torn 84 84
Delivered as Unsterile Product 37 37
Manufacturing, Packaging or Shipping Problem 32 32
Component Misassembled 24 24
Packaging Problem 23 23
Device Contaminated During Manufacture or Shipping 21 21
Material Frayed 20 20
Biocompatibility 17 17
Device Markings/Labelling Problem 14 14
Material Integrity Problem 14 14
Nonstandard Device 12 12
Inadequacy of Device Shape and/or Size 10 10
Defective Component 7 7
Product Quality Problem 6 6
Component Missing 5 5
Material Discolored 5 5
Patient-Device Incompatibility 5 5
Material Twisted/Bent 4 4
Insufficient Information 4 4
Device Contamination with Chemical or Other Material 3 3
Dull, Blunt 3 3
Mechanical Problem 3 3
Difficult to Remove 3 3
Migration 3 3
Tear, Rip or Hole in Device Packaging 2 2
Unraveled Material 2 2
Component Incompatible 2 2
Contamination /Decontamination Problem 2 2
Appropriate Term/Code Not Available 2 2
Mechanics Altered 2 2
Patient Device Interaction Problem 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Remove Packaging Material 1 1
Corroded 1 1
Entrapment of Device 1 1
Fracture 1 1
Unsealed Device Packaging 1 1
Use of Device Problem 1 1
Material Too Rigid or Stiff 1 1
Device Slipped 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1135 1135
No Consequences Or Impact To Patient 492 492
Inflammation 177 177
Erythema 131 131
Unspecified Infection 84 84
Swelling/ Edema 75 75
Pain 71 71
Fluid Discharge 71 71
Insufficient Information 67 67
Not Applicable 59 59
Hemorrhage/Bleeding 49 49
No Known Impact Or Consequence To Patient 45 45
Purulent Discharge 41 41
Wound Dehiscence 40 40
Skin Inflammation/ Irritation 30 30
Itching Sensation 27 27
Impaired Healing 27 27
Hypersensitivity/Allergic reaction 26 26
Post Operative Wound Infection 19 19
No Code Available 15 15
Pocket Erosion 15 15
Foreign Body Reaction 13 13
No Information 12 12
Fistula 11 11
Granuloma 9 9
Abscess 9 9
Foreign Body In Patient 9 9
Unspecified Tissue Injury 9 9
Blood Loss 8 8
Discomfort 7 7
Necrosis 7 7
Local Reaction 6 6
Failure to Anastomose 6 6
No Patient Involvement 6 6
Radiation Exposure, Unintended 5 5
Hernia 5 5
Fever 5 5
Scar Tissue 5 5
Unintended Radiation Exposure 5 5
Swelling 4 4
Pneumothorax 3 3
Burning Sensation 3 3
Obstruction/Occlusion 3 3
Sepsis 3 3
Eye Injury 3 3
Bacterial Infection 3 3
Erosion 3 3
Cyst(s) 3 3
Adhesion(s) 2 2
Hematoma 2 2
Skin Tears 2 2
Abdominal Distention 2 2
Ptosis 2 2
Device Embedded In Tissue or Plaque 2 2
Perforation of Vessels 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cardiac Tamponade 1 1
Synovitis 1 1
Thrombosis 1 1
Urinary Retention 1 1
Ulcer 1 1
Reaction 1 1
Numbness 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Joint Dislocation 1 1
Thrombosis/Thrombus 1 1
Cardiovascular Insufficiency 1 1
Needle Stick/Puncture 1 1
Premature Labor 1 1
Dysphagia/ Odynophagia 1 1
Arrhythmia 1 1
Abdominal Pain 1 1
Abortion 1 1
Death 1 1
Capsular Contracture 1 1
Rash 1 1
Nerve Damage 1 1
Paralysis 1 1
Perforation 1 1
Incontinence 1 1
Laceration(s) 1 1
Intraocular Pressure Increased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP II Jan-29-2024
2 Covidien, LP II Feb-25-2023
3 Ethicon, Inc. II Jul-02-2020
4 Ethicon, Inc. II Jan-16-2019
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