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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, nonabsorbable
Product CodeGAO
Regulation Number 878.4495
Device Class 2

MDR Year MDR Reports MDR Events
2019 14 14
2020 3 3
2021 8 8
2022 13 13
2023 7 7
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Material Separation 5 5
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Entrapment of Device 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
No Consequences Or Impact To Patient 12 12
Pain 4 4
Abscess 3 3
Hemorrhage/Bleeding 3 3
Unspecified Infection 3 3
Inflammation 3 3
Skin Inflammation/ Irritation 3 3
Swelling/ Edema 2 2
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Not Applicable 2 2
Fistula 2 2
Erythema 2 2
Eye Injury 1 1
Death 1 1
Purulent Discharge 1 1
Granuloma 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Scar Tissue 1 1
Sepsis 1 1
Vertigo 1 1
Vomiting 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 1
Post Operative Wound Infection 1 1
Ptosis 1 1
Fluid Discharge 1 1
Ischemia Stroke 1 1
Blister 1 1
Insufficient Information 1 1
Itching Sensation 1 1
Wound Dehiscence 1 1

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