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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, absorbable
Product CodeGAK
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2019 24 24
2020 22 22
2021 13 13
2022 20 20
2023 33 33
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 54 54
Break 50 50
Material Separation 13 13
Material Frayed 4 4
Material Integrity Problem 3 3
Appropriate Term/Code Not Available 3 3
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Unspecified Infection 23 23
No Consequences Or Impact To Patient 23 23
Insufficient Information 15 15
Pain 14 14
Wound Dehiscence 13 13
Hemorrhage/Bleeding 9 9
Not Applicable 8 8
Post Operative Wound Infection 7 7
Impaired Healing 7 7
Inflammation 6 6
Erythema 6 6
No Code Available 6 6
Swelling/ Edema 5 5
Hematoma 5 5
Abscess 5 5
Pocket Erosion 5 5
Scar Tissue 3 3
Urinary Retention 3 3
Failure to Anastomose 3 3
Fever 3 3
Foreign Body In Patient 3 3
Blood Loss 2 2
Abdominal Distention 2 2
Fluid Discharge 2 2
Hypersensitivity/Allergic reaction 2 2
Death 2 2
Purulent Discharge 2 2
Perforation 2 2
Urinary Tract Infection 1 1
Obstruction/Occlusion 1 1
Hernia 1 1
Deformity/ Disfigurement 1 1
Sepsis 1 1
Seroma 1 1
Swelling 1 1
Itching Sensation 1 1
Necrosis 1 1
Abrasion 1 1
Anaphylactic Shock 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Incontinence 1 1
Fistula 1 1
Eye Injury 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1

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