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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
2018 6 6
2019 14 14
2020 3 3
2021 8 8
2022 13 13
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Material Separation 4 4
Manufacturing, Packaging or Shipping Problem 2 2
Unraveled Material 1 1
Device Markings/Labelling Problem 1 1
Appropriate Term/Code Not Available 1 1
Detachment Of Device Component 1 1
Entrapment of Device 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 13 13
No Clinical Signs, Symptoms or Conditions 9 9
Pain 5 5
Unspecified Infection 3 3
Inflammation 3 3
Not Applicable 3 3
Skin Inflammation/ Irritation 3 3
Swelling/ Edema 2 2
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Hemorrhage/Bleeding 2 2
Wound Dehiscence 2 2
Abscess 2 2
Erythema 2 2
Fistula 2 2
Granuloma 1 1
Eye Injury 1 1
Death 1 1
Purulent Discharge 1 1
Scar Tissue 1 1
Sepsis 1 1
Vertigo 1 1
Vomiting 1 1
Injury 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 1
Post Operative Wound Infection 1 1
Ptosis 1 1
Fluid Discharge 1 1
Itching Sensation 1 1
Insufficient Information 1 1
Ischemia Stroke 1 1
Blister 1 1

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